# Bayer **Petition 09 -**  **328 -**  **01 for Determination of Non**  **** **regulated Status of Double Herbicide**  **- tolerant**  **Soybean ( Glycine Max** **) Event FG72 OECD Unique Identifier:**  **FG72** 

## Draft Environmental Assessment **April 2012 Agency Contact**  **Cindy Eck Biotechnology Regu**  **latory Services 4700 River Road**  **USDA, APHIS Riverdale, MD 20737**  **Fax: (301) 734 -**  **8669** The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, sex, religion, a ge, disability, political beliefs, sexual orientation, or marital or family status. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, au diotape, etc.) should contact USDA’S TARGET Center at (202) 720

–2600 (voice and TDD). To file a complaint of discrimination, write USDA, Director, Office of Civil Rights, Room 326

–W, Whitten Building, 1400 Independence Avenue, SW, Washington, DC 20250

– 94 10 or call (202) 720

– 5964 (voice and TDD). USDA is an equal opportunity provider and employer. Mention of companies or commercial products in this report does not imply recommendation or endorsement by the U.S. Department of Agriculture over others not mentioned. USDA neither guarantees nor warrants the standard of any product mentioned. Product names are mentioned solely to report factually on available data and to provide specific information. This publication reports research involving pesticid es. All uses of pesticides must be registered by appropriate State and/or Federal agencies before they can be recommended.ii

**TABLE OF CONTENTS** LIST OF TABLES ................................ ................................ ................................ ....................... V LIST OF FIGURES ................................ ................................ ................................ .................. VII ACRONYMS AND ABBREVIAT IONS ................................ ................................ ................ VIII 1 PURPOSE AND NEED ................................ ................................ ................................ ........ 1 1.1 Coordinated Framework Review and Regulatory Review ................................ ............. 1 1.2 Petition for Determination of Nonregulated Status: Double Herbicide - tolerant Soy bean Event FG 72 ................................ ................................ ................................ ..... 3 1.3 Purpose of Product ................................ ................................ ................................ ......... 3 1.4 Purpose and Need for APHI S Action ................................ ................................ ............. 4 1.5 Public Involvement ................................ ................................ ................................ ........ 4 1.6 Issues Considered ................................ ................................ ................................ ........... 5 2 AFFECTED ENVIRONMENT ................................ ................................ ............................ 6 2.1 Agricultural Production of Soy bean ................................ ................................ ............... 6 2.1.1 Acreage and Range of Soy bean Production ................................ ............................ 6 2.1.2 Agronomic Practices ................................ ................................ ............................... 7 2.1.3 Organic So ybean Production ................................ ................................ ................ 10 2.2 Phy sical Environment ................................ ................................ ................................ .. 11 2.2.1 Soil Quality ................................ ................................ ................................ ........... 11 2.2.2 Water Resources ................................ ................................ ................................ ... 12 2.2.3 Air Quality ................................ ................................ ................................ ............ 12 2.2.4 Climate Change ................................ ................................ ................................ ..... 12 2.3 Biological Resources ................................ ................................ ................................ .... 13 2.3.1 Animal Communities ................................ ................................ ............................ 13 2.3.2 Plant Communities ................................ ................................ ................................ 14 2.3.3 Gene Flow and Weediness ................................ ................................ .................... 15 2.3.4 Microorganisms ................................ ................................ ................................ .... 15 2.3.5 Biodiversity ................................ ................................ ................................ ........... 15 2.4 Human Health ................................ ................................ ................................ .............. 16 2.5 Animal Feed ................................ ................................ ................................ ................. 17 2.6 Socioeconomic ................................ ................................ ................................ ............. 17 2.6.1 Domestic Economic Environment ................................ ................................ ........ 17 2.6.2 Trade Economic Environment ................................ ................................ .............. 19 3 AL TERNATIVES ................................ ................................ ................................ ............... 20 3.1 No Action Alternative: Continuation as a Regulated Article ................................ ...... 20iii

3.2 Preferred Alternative: Determination that FG72 Soy bean is No Longer a Regulated Article ................................ ................................ ................................ ......... 20 3.3 Alternatives Considered But Rejected from Further Consideration ............................ 21 3.3.1 Prohibit Any

FG72 So yb ean from Being Released ................................ .............. 21 3.3.2 Approve the Petition in Part ................................ ................................ .................. 21 3.3.3 Isolation Distance between FG72 and Non - GE Soy bean Production and Geographical Restrictions ................................ ................................ .............. 22 3.3.4 Requirement of Testing for FG72 So ybean ................................ .......................... 22 3.4 Comparison of Alternatives ................................ ................................ ......................... 23 4 ENVIRONMENTAL CONSEQ UENCES ................................ ................................ ......... 25 4.1 Scope of Ana ly sis ................................ ................................ ................................ ......... 25 4.2 Agricultural Production of Soy bean ................................ ................................ ............. 26 4.2.1 Acreage and Range of Soy bean Production ................................ .......................... 26 4.2.2 Agronomic Practices ................................ ................................ ............................. 26 4.2.3 Organic So ybean Production ................................ ................................ ................ 32 4.3 Phy sical Environment ................................ ................................ ................................ .. 33 4.3.1 Soil Quality ................................ ................................ ................................ ........... 33 4.3.2 Water Resources ................................ ................................ ................................ ... 34 4.3.3 Air Quality ................................ ................................ ................................ ............ 36 4.3.4 Climate Change ................................ ................................ ................................ ..... 37 4.4 Biological Resources ................................ ................................ ................................ .... 38 4.4.1 Animal Communities ................................ ................................ ............................ 38 4.4.2 Plant Communities ................................ ................................ ................................ 40 4.4.3 Gene Flow and Weediness ................................ ................................ .................... 43 4.4.4 Microorganisms ................................ ................................ ................................ .... 44 4.4.5 Biodiversity ................................ ................................ ................................ ........... 45 4.5 Human Health ................................ ................................ ................................ .............. 46 4.6 Animal Feed ................................ ................................ ................................ ................. 47 4.7 Socioeconomic Impacts ................................ ................................ ................................ 48 4.7.1 Domestic Economic Environment ................................ ................................ ........ 48 4.7.2 Trade Economic Environment ................................ ................................ .............. 50 5 CUMULAT IVE IMPACTS ................................ ................................ ................................ 51 5.1 Assumptions Used for Cumulative Impacts Anal ysis ................................ .................. 51 5.2 Cumulative Impacts: Acreage and Range of Soy bean Production .............................. 51 5.3 Cumulative Impacts: Agronomic Practices ................................ ................................ .. 52 5.4 Cumulative Impacts: Organic Soy bean Production ................................ ..................... 53 5.5 Cumulative Impacts: Soil Quality ................................ ................................ ................ 54 5.6 Cumulative Impacts: Water Resources ................................ ................................ ........ 54 5.7 Cumulative Impacts: Air Quality ................................ ................................ ................. 55iv

5.8 Cumulative Impacts: Climate Change ................................ ................................ .......... 55 5.9 Cumulative Impacts: Animal Communities ................................ ................................ . 55 5.10 Cumulative Impacts: Plant Communities ................................ ................................ ..... 56 5.11 Cumulative Impacts: Gene Flow and Weediness ................................ ......................... 59 5.12 Cumulative Impacts: Microorganisms ................................ ................................ ......... 59 5.13 Cumulative Impacts: Biodiversity ................................ ................................ ................ 59 5.14 Cumulative Impacts: Human Health ................................ ................................ ............ 60 5.15 Cumulative Impacts: Animal Feed ................................ ................................ ............... 60 5.16 Cumulative Impacts: Domestic Economic Environment ................................ ............. 61 5.17 Cumulative Impacts: Trade Economic Environment ................................ ................... 61 6 THREATENED AND ENDAN GERED SPECIES ................................ ........................... 62 6.1 Potential Effects of FG72 Soy bean on TES ................................ ................................ . 64 6. 2 Potential Effects of the use of Gl yphosate and Isoxaflutole ................................ ........ 66 7 CONSIDERATION OF EXE CUTIVE ORDERS, STAND ARDS, AND TREATIES RELATIN G TO ENVIRONMENTAL I MPACTS .............................. 70 7.1 Executive Orders with Domestic Implications ................................ ............................. 70 7.2 International Implications ................................ ................................ ............................ 72 7.3 Compliance with Clean Water Act and Clean Air Act ................................ ................ 73 7.4 Impacts on Unique Characteristics of Geographic Areas ................................ ............ 74 7.5 National Historic Preservation Act of 1966 as Amended ................................ ............ 75 8 LIST OF PREPARERS ................................ ................................ ................................ ....... 76 9 REFERENCES ................................ ................................ ................................ ................... 77 10 APPENDIX A: I SOXAFLU TOLE

– DESCRIPTION AND CURRENT USES ................................ ................................ ................................ ................................ .. 91 11 APPENDIX B: GLYPHOSA TE

– SUMMARY OF ENVIRONMENTAL FATE AND TOXI CI TY PR OFILE ................................ ................................ ................. 106 12 APPENDIX C: SUPPLEMENTAL FIGURES AND TAB LES ................................ ...... 113 13 APPENDIX D: SOYBEAN COMMODITY PRODUC TI ON ................................ ......... 120v

**LIST OF TABLES** Table 1. Assessment of resistance risk b y agricultural management options. ............................... 4 Table 2. U.S. export markets for so ybean and so ybean products. ................................ ............... 19 Table 3. Summary

of issues of potential impacts and consequences of alternatives. .................. 23 Table 4. Maximum soy

bean herbicide application rates ................................ ............................. 31 Table 5. Use of gly

phosate and isoxaflutole (IFT) in U.S. corn production, 2000

– 2010. ......... 32 Table 6. Environmental Impact Quotient (EIQ) of soy bean herbicides with respect to several factors related to water resources ................................ ................................ ..................... 36 Table 7. Summary

of the most sensitive endpoints from submitted terrestrial toxicity studies for isoxaflutole (IFT) ................................ ................................ ................................ ........ 39 Table 8. Summary

of the most sensitive endpoints for submitted aquatic tox icity studies for isoxaflutole (IFT) ................................ ................................ ................................ .......................... 39 Table 9. Control of common broadleaf and grassy weeds b y isoxaflutole (IFT) (Balance® Pro) ................................ ................................ ................................ ............................. 41 Table 10. Control of glyphosate - resistant broadleaf and grass y weeds found in soy bean by isoxaflutole (IFT) (Balance ® Pro) ................................ ................................ ................................ . 42 Table 11. Use of gly

phosate and mesotrione in U. S. corn production, 2001

– 2010. ................. 53 Table 12. Gl yphosate - resistant weed (in so ybean fields) control profiles for isoxaflutole (IFT) and mesotrione ................................ ................................ ................................ .................... 57 Table A1. Summary

of environmental fate information for IFT and DKN. ................................ 93 Table A2. Estimated isoxaflutole (IFT) registration review tim eline. ................................ ......... 94 Table A3. Acute toxicity profile of isoxaflutole (IFT) and degradation products. ...................... 96 Table A4. Subchronic and chronic t oxicity and genotoxicity

profile: Isoxaflutole (IFT) and products. ................................ ................................ ................................ ................................ ........ 96 Table A5. Specific use directions for Balance® PRO herbicide alone as part of a planned sequential weed control program ................................ ................................ ................................ 103 Table A6. Proposed directions for use of isoxaflutole (IFT) on isoxaflutole - tolerant soy bean varieties ................................ ................................ ................................ ................................ ....... 103 Table A7. Specific use directions for Balance® PRO herbicide applied alone, as a tank - mix, or as part of a planned sequential program for weed control in isoxaflutole (IFT) tolerant soy bean varieties ................................ ................................ ................................ ......................... 104 Table B1. Ph ys ical and chemical properties of gl yphosate. ................................ ...................... 107 Table B2. Environmental fate data for gl yphosate. ................................ ................................ ... 108vi

Table B3. Aquatic toxicity profile for gl yphosate and/or its salts ................................ ............. 110 Table B4. Terrestrial toxicity profile for gl yphosate and/or its salts. ................................ ........ 111 Table C1. Soy

bean acreage in U.S. states, 2010. ................................ ................................ ....... 114 Table C2. Irrigation of soy bean acres in U.S. states, 2007. ................................ ....................... 115 Table C3. Common soybean insect pests. ................................ ................................ ................. 117 Table C4. Common weeds in soy bean production: Midwest Region ................................ ........ 117 Table C5. Common weeds in soy bean production: Eastern coastal Region .............................. 118 Table C6. Common weeds in soy bean production: Mid - south Region ................................ ..... 118 Table D1. Industrial so ybean oil production 2008 - 2009. ................................ ........................ 122vii

**LIST OF FIGURES** Figure 1. U.S. so ybean production, 2010 . ................................ ................................ ...................... 7 Figure 2. Adoption of GE herbicide - tolerant soy bean and gl yphosate use on U.S. soy bean fields, 1990

– 2006 ................................ ................................ ................................ .......................... 9 Figure 3. Extent of gl yp hosate use and diversity of herbicides applied in U.S. soy bean production, 1990

– 2006. ................................ ................................ ................................ ................ 9 Figure 4. U.S. certified organic so ybean, 2008. ................................ ................................ ........... 11 Figure 5. Gl yphosate - resistant weeds in the U.S. soy bean fields. ................................ ............... 14 Figure 6. General flow of U.S. soy bean commodities. ................................ ................................ 18 Figure 7. U.S. inventory

and use of harvested soybeans, 2010 ................................ ................... 18 Figure 8. Percent and application rate of nitrogen fertilization in U.S. soy bean pro duction, 1992

– 2006. ................................ ................................ ................................ ................................ .. 28 Figure 9. Comparison of ty pical so ybean fatty acids and crude protein between FG72 soy bean and Jack ................................ ................................ ................................ ........................... 49 Figure 10. Weed control provided by herbicides isoxaflutole (IFT) and mesotrione. ................. 57 Figure A1. Metabolic/degradative fate of isoxaflutole (IFT) in plants and soil .......................... 91 Figure A2. Activity

of isoxaflutole (IFT) in plants ................................ ................................ ...... 92 Figure C1. Global distri bution of herbicide - resistant bioty pes, 2010 ................................ ........ 113 Figure C2. Global herbicide - resistant bioty pes b y mode of action, 1950

– 2010 ..................... 113viii

**ACRONYMS AND ABBREVI ATIONS**  **4 -**  **HPPD** 4 - hydroxy phen ylpy ruvate dioxygenase **AIA** advanced informed agreement **AMS** Agricultural Marketing Service **AOSCA** American Organization of Seed Certifying Agencies **APHIS** Animal and Plant Health Inspection Service **BRS** Biotechnology Regulatory

Service s (within USDA

–APHI S) **Bt** Bacillus thuringiensis protein **CAA** Clean Air Act **CBD** Convention on Biological Diversity **CEQ** Council on Environmental Quality **CFR** Code of Federal Regulations (United States) **CH 4**  methane **CO 2**  carbon dioxide **CWA** Clean Water Ac t **DNA** deox yribonucleic acid **DKN** diketonitrile **EA** environmental assessment **EFED** Environmental Fate and Effects Division **EIQ** Environmental Impact Quotient **EIS** environmental impact statement **EO** Executive Order **EPA** U.S. Environmental Protection Agency **EPSPS** 5 - enolpy

ruvylshikimate - 3 - phosphate s ynthase **ESA** Endangered Species Act of 1973 **ESPP** Endangered Species Protection Program **FDA** U.S. Food and Drug Administration **FFDCA** Federal Food, Drug, and Cosmetic Act **FI FRA**  Federal Insecticide, Fungicide, and Rodenticide Act **FSANZ** Food Standards Australia New Zealand **FR** Federal Register **FQ PA**  Food Quality Protection Actix

**GE** geneticall y engineered **GHG** greenhouse gas **HED** Health Effects Division **IFT** isoxaflutole **IP** Id entity

Preservation **IPCC** Intergovernm ental Panel on Climate Change **ISPM** International Standard for Phytosanitary Measure **IPPC** International Plant Protection Convention **LD50** lethal dose that kills 50% of the animals being tested **LMO** Living modified organism **MoA** Mode of Action **N 2**  **O** nitrous oxide **NABI** North American Biotechnology Initiative **NAPPO** North American Plant Protection Organization **NEPA** National Environmental Policy Act of 1969 and subsequent amendments **NHPA** National Historic Preservation Act **NMFS** National Marine Fisheries Serv ice **NOEL** no observable effect level **NOP** National Organic Program **NPS** non - point source **NRC** National Research Council **OECD** Organization for Economic Cooperation and Development **PI P**  Plant incorporated protectants **PPRA** Plant Pest Risk Assessment **PPA** Pl ant Protection Act **PRA** Pest Risk Assessment **RSPM** Regional Standards for Phy tosanitary Measures **RUP** Restricted Use Pesticide **TES** threatened and endangered species **TSCA** Toxic Substances Control Act **U.S.** United States **USFWS** United States Fish and Wildl ife Services **USDA** U.S. Department of Agriculturex

**USDA -**  **ERS** U.S. Department of Agriculture - Economic Research Service **USDA -**  **FAS** U.S. Department of Agriculture - Foreign Agricultural Service **USDA -**  **NASS** U.S. Department of Agriculture -National Agricultural Stati stics Service **USDA -**  **NOP** U.S. Department of Agriculture -National Organic Program **USC** United States Code **WPS** Worker Protection Standard for Agricultural Pesticides1

**1 PURPOSE AND NEED**  **1.1 Coordinated Framework Review and Regulatory Review**  "Protecting American agriculture" is the basic charge of the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS). APHI S provides leadership in ensuring the health and care of plants and animals. The agency improves agricultural productivity

and competitiveness, and contributes to the national econom y and the public health. USDA asserts that all methods of agricultural production (conventional, conventional with genetically engineered crops , and organic s ys tems) can provide benefits to the environment, consumers, and farm income. Since 1986, the United States government has regulated geneticall y engineered (GE) organisms pursuant to a regulatory

framework known as the Coordinated Framework for the Regulation of Biotechnology

(Coordin ated Frame work) ( 51 FR 23302 ; 57 FR 22984 ) . The Coordinated Framework, published by the Office of Science and Technology Policy , describes th e comprehensive federal regulatory policy for ensuring the safety of biotechnology research and products and explains how federal agencies will use existing Federal statutes in a manner to ensure public health and environmental safety while maintaining regulatory flexibility to avoid impeding the growth of the biotechnology industry . The Coordinated Framework is based on several important guiding principles: (1) agencies should define those transgenic organisms subject to review to the extent permitted by their respective statutory authorities; (2) agencies are required to focus on the characteristics and risks of the biotechnology product, not the process by which it is created; (3) agencies are mandated to exercise oversight of GE organisms only when ther e is evidence of “unreasonable” risk. The Coordinated Framework explains the regulatory roles and authorities for the three major agencies involved in regulating GE organisms: USDA APHI S, the Environmental Protection Agency (EPA) , and the Food an d Drug Adm inistration (FDA). USDA - APHIS APHI S regulations at 7 Code of Federal Regulations (CFR) part 340, which were promulgated pursuant to authority

granted by

the Plant Protection Act, as amended (7 United States Code (U.S.C.) 7701

– 7772), regulate the introducti on (importation, interstate movement, or release into the environment) of certain GE organisms and products. A GE organism is no longer subject to the plant pest provisions of the Plant Protection Act or to the regulatory requirements of 7 CFR part 340 wh en APHIS determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated article if the donor organism, recipient organism, vector, or vector agent used in engineering the organism belongs to one of the taxa listed in the regulation (7 CFR 340.2) and is also considered a plant pest. A GE organism is also regulated under Part 340 when APHI S has reason to believe that the GE organism may be a plant pest or APHI S does not have information to determine if the GE organism is un likely to pose a plant pest risk. A person may

petition the agency

that a particular regulated article is unlikely to pose a plant pest risk, and, therefore, is no longer regulated under the plant pest provisions of the Plant Protection Act (PPA) or the r egulations at 7 CFR 340. The petitioner is required to provide2

information under § 340.6(c)(4) related to plant pest risk that the agency may use to determine whether the regulated article is unlikely to present a greater plant pest risk than the unmodifi ed organism. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act when APHIS determines that it is unlikely to pose a plant pest risk. Under the authority

of the plant pest provisions of the Plant Protection Act and 7 CFR part 340, APHI S has issued regulations for the safe development and use of GE organisms. As required by 7 CFR 340.6, APHIS must respond to petitioners that request a determination of the regulated status of GE org anisms . When a petition for nonregulated status is submitted, APHI S must make a determination if the GE organism is unlikely to pose a plant pest risk. If APHI S determines base d on its Plant Pest Risk Assessment (PPRA) that the GE organism is unlikely to pose a plant pest risk, the geneticall y engineered organism is no longer subject the plant pest provisions of the Plant Protection Act and 7 CFR part 340. Environmental Protection Agency Under the Federal Insecticide, Fungicide, and Rodenticid e Act ( FIFRA ) (7 U.S.C. 136 et seq. ) , EPA regulates the use of pesticides, including plant - incorporated protectants, requiring registration of a pesticide for a specific use prior to distribution or sale of the pesticide for a proposed use pattern. EPA ex amines the ingredients of the pesticide; the particular site or crop on which it is to be used; the amount, frequency , and timing of its use; and storage and disposal practices . Prior to registration for a new use for a new or previously registered pestic ide, EPA must determine through testing that the pesticide will not cause unreasonable adverse effects on humans, the environment, and non - target species whe n used in accordance with label instructions . EPA must also approve the language used on the pesti cide label in accordance with 40 CFR part 158. Once registered, a pesticide may not legall y be used unless the use is consistent with the approved directions for use on the pesticide's label or labeling. The overall intent of the label is to provide clear directions for effective product performance while minimizing risks to human health and the environment . EPA also sets tolerances for residues of pesticides on and in food and animal feed, or establishes an exemption from the requirement for a toleranc e, under the Federal Food, Drug, and Cosmetic Act (FFDCA). EPA is required, before establishing pesticide tolerance, to reach a safety determination based on a finding of reasonable certainty of no harm under the FFDCA, as amended by the Food Quality Prot ection Act of 1996 (FQPA). FDA enforces the pesticide tolerances set by EPA. Food and Drug Administration FDA regulates GE organisms under the authority of the FFDCA (21 U.S.C. 301 et seq. ). The FDA published its policy statement concerning regulation of p roducts derived from new plant varieties, including those derived from genetic engineering , in the Federal Register on May 29, 1992 ( 57 FR 22984 ) . Under this policy , FDA implements a voluntary consultation process to ensure that human food and animal feed safety issues or other regulatory i ssues, such as labeling, are resolved before commercial distribution of bioengineered food. This voluntary consultation process provides a way

for developers to receive assistance from FDA in complying with their obligations under Federal food safety laws prior to marketing.3

**1.2 Petition for Determination of Nonregulated Status: Double Herbicide**  **- tolerant**  **Soybean Event FG72** Baye r CropScience of Research Triangle Park, NC sub mitted petition 09 - 328 - 01 to APHI S in June 2011 seeking a determination of nonregulated status for soy bean event FG72 that can tolerate exposure to the herbicides gl yphosate and isoxaflutole (IFT). FG72 soy bean is currently regulated under 7 CFR part 340. Interstate movements and field trials of FG72 soy bean have been conducted under permit s issued or notifications acknowledged b y APHI S since 2001 . These field trials were conducted in diverse growing regions within the U.S., including Indiana, Io wa, Nebraska, Florida, Arizona, I llinois, Michigan, Missouri, and Minnesota. Data resulting fro m these field trials are described in the FG72 petition ( Baye r, 2011c ) and anal yz ed for plant pest risk in the USDA - APHI S Plant Pest Risk Assessment (PPRA) (USDA - APHI S, 2012b ) . The petition stated that APHI S should not regulate FG72 soy bean because it doe s not present a plant pest risk. In the event of a determination of nonregulated s tatus, the nonregulated status would include FG72 so ybean , an y progen y derived from crosses between FG72 and conventional soy

bean , including crosses of FG72 with other biote chnology - derived soy bean that are no longer subject to subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. **1.3 Purpose of Product**  Weed management is one of the largest concerns in soy bean productio n. The development of gl yphosate - resistant weeds has generally compounded this concern. Several management options are available to manage current gl yphosate - resistant weed populations and limit the potential development of gl yphosate resistance in other weed species ( Table 1 ). Reflecting the first of these potential management options, the development of FG72 so yb ean facilitates the use of an additional herbicide with a different mode of action (MoA) to control soy bean weed populations, including those weed populations that are resistant to gl yphosate. Under t ypical field conditions, application of gl yp hosate or IFT would disrupt soy bean aromatic amino acid and carotenoid biosy nthesis, respectively ( RSC, 2011 ; USDA - APHI S, 2008 ) . FG72 soy bean is engineered to tolerate exposure to the herbicides gl yphosate and IFT. This double herbicide - tolerant phenoty pe is enabled by

stable introduction of the 2mEPSPS and HPPD W336 proteins that correspondingl y confer gl yphosate and IFT tolerance. 2mEPSPS is derived from Zea mays and HPPD W336 is derived from the A32 strain of Pseudomonas fluorescens . Both introduced proteins impart herbicide tolerance in a mechanisticall y similar manner, where 2mEPSPS and HPPD W336 are less susceptible to competitive inhibition by gl yphosate and IFT, respectivel y, than native soy bean EPSPS ( 5 - enolpyruv yl shikimate - 3 - phosphate sy nthase ) or 4 - HPPD (4 - hydroxy

phen yl py ruvate dioxygenase) proteins.4

**Table 1**  **.** Assessment of resistance risk by agricultural management options. Management Option Risk of Resistance Low Moderate High Herbicide mix or rotation in cropping system > 2 MoA * 2 MoA * 1 MoA * Weed control in cropping system Cultural ** , mechanical, and chemical Cultural ** and chemical Chemical only Use of same MoA * per season Once More than once Many times Cropping system Ful l rotation Limited rotation No rotation Resistance status to MoA* Unknown Limited Common Weed infestation Low Moderate High Control in the last three years Good Declining Poor *Mode of Action. ** Cultural control includes stubble burning, competitive c rops, stale seedbeds, etc. See HRAC guidelines for more details. Source: HRAC ( 2012 ) . **1.4 Purpose and Need for APHIS Action**  As required b y 7 CFR 340.6, APHI S must respond to petitioners that request a determination of the regulated status of genetically engineered organisms, including GE plants such as FG72 soy bean. AP HI S has prepared this Environmental A ssessment (EA) to consider the potential environmental effects of an agency determination of nonregulated status consistent with Council of Environme ntal Quality ’s (CEQ) NEPA regulations and the USDA and AP HI S NEPA implementing regulations and procedures(40 CFR parts 1500 - 1508, 7 CFR part 1b, and 7 CFR part 372). This EA has been prepared in order to specificall y evaluate the effects on the quality of the human environment 1 that may result from a determinati on of nonregulated status of FG72 soy bean . **1.5 Public Involvement**  APHI S routinel y seeks public comment on EAs prepared in response to petitions seeking a determination of nonregulated status of a regulated GE organism . APHIS does this through a notice publishe d in the Federal Register . The issues discussed in this EA were developed b y considering the public concerns as well as issues raised in public comments submitted for other EAs of GE organisms, concerns raised in lawsuits, as well as those issues of concer n that have been raised b y various stakeholders. These issues, including those regarding the agricultural production of soy

bean using various production methods and the environmental and food/feed safety of GE plants were addressed to anal yz e the potential environmental impacts of FG72 soy bean . 1 Under NEPA regulations, the “human environment” includes “the natural and physical environment and the relationship of people with that environment” (40 CFR §1508.14).5

This EA, the petition submitted by Bayer CropScience , and APHIS’s PPRA will be available for public comment for a period of 60 days (7 CFR § 340.6(d)(2)). Comments received by the end of the 60 - day

period will be ana ly

zed and used to inform APHI S’ determination decision of the regulated status of FG72 soy bean and to assist APHI S in determining whether an Environmental Impact Statement (EIS) is required prior to the determination decision of the regulated status of thi s soy bean variety. **1.6 Issues Considered**  The list of resource areas considered in this draft EA were developed b y APHI S through experience in considering public concerns and issues raised in public comments submitted for other EAs of GE organisms. The resourc e areas considered also address concerns raised in previous and unrelated lawsuits, as well as issues that have been raised b y various stakeholders in the past. The resource areas considered in this EA can be categorized as follows: Agricultural Produc tion Considerations:  Acreage and range of soy bean p roduction  Agronomic p ractices  Organic soy

bean p roduction Environmental Considerations:  Soil Quality  Water resources  Air quality  Climate c hange  Animal communities  Plant communities  Gene f

low and weediness  Microorganisms  Biodiversity Human Health Considerations:  Public h ealth and worker safety Livestock Health Considerations:  Animal feed/livestock health Socioeconomic Considerations:  Domestic economic e nvironment  Trade economic e nvironment6

**2 AFFECTED ENVIR**  **ONMENT 2.1**  **Agricultural Production of Soybean** 2.1.1 Acreage and Range of Soy bean Production Soy bean production in the U.S. extends over a wide range of geographies and regions, and is generall y grown from North Dakota eastward. In 2010 , 76.6 million acres of soy beans were cultivated in at least 31 states (USDA - NASS, 2011c ) . Also in the 2010 growing season, more than one million acres of soy beans were harvested in the following 18 states (from h ighest to lowest acreage): Iowa, Il linois, Minnesota, Indiana , Nebraska, Missouri, Ohio, Kansas, South Dakota, North Dakota, Arkansas, Michigan, Mississippi, Wisconsin, North Carolina, Tennessee, Kentucky, and Louisiana (Figure 1 and Table C 1 , Appendix C ). Due to increased domestic and international demand for soy beans and its products, the U.S. soy bean harvest is projected to slightly increase to approximately 79.5 million acres by

2020 (USDA - ERS, 201 1c ) . In general, s oy

bean is profitably

grown on high quality agricultural land, not lands of lower productivity ( EIA, 2007 ; USDA -NASS, 2011b ) . Much of the high quality land in the U.S. is already committed to agricultural production ( EPA, 2007 ) and in 2002, the USDA Economic Research Service (USDA - ERS) estimated that only 2.1 percent of cropland was idle ( Lubowski et al., 2002 ) . At the same time , total U.S. agricultural acreage decreased ( EIA, 2007 ) . To satisfy greater soy

bean demand, additional soy bean acreage was general ly planted at the expense of alternative crops, such as cotton or hay , with minor contributions from land exiting Conservation Reserve Program (CRP) agreements ( O'Brian, 20 10 ; USDA - ERS, 2011e ) . Consequently , it is unlikely that previousl y uncultivated land will be managed for future soy bean production, but rather that growth of soybean production will compete with other agricultural plantings ( EIA, 2007 ; USDA - ERS, 2011d) .7

**Figure 1**  **.** U.S. soy

bean production, 2010. Source: USDA -NASS ( 2011c ) . 2.1.2 Agronomic Practices In this EA, c onventional farming is defined as an y farming s ys tem where sy nthetic pesticides or fert ilizers may

be used. Conventional farming covers a broad scope of farming practices, ranging from farmers who occasionall y use s ynthetic pesticides and fertilizers to those farmers whose harvest depends on regular inputs of s ynthetic pesticides and fertil izers . C onventional farming also includes the use of GE varieties that are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. Soy bean varieties are developed and adapted to certain geographical zones (i.e., maturity groups) ( Helsel and Minor, 1993 ; NSRL , 2011 ) . Additionally , GE herbicide - tolerant soy bean varieties represents the most common soy bean variety cultivated in the U.S., accounting for 94 percent of soy bean varieties planted in 2011 (USDA - ERS, 2011a) . The broad adoption of GE herbicide tolerant soy

bean production sy stems is attributed to the simplification of herb icide application practices and positive contributions to productivity and yield ( Carpenter and Gianessi, 1999 ; Fernandez - Cornejo and McBride, 2000 ) . Among the GE herbicide - tolerant soy bean varieties commerciall y available, gl yphosate - tolerant varieties represent the vast majority that is planted in U.S. production fields. Since its introduction in 1996, domestic adoption of gl yphosate - tolerant soy bean varieties expanded to the majority of the market (NRC, 2010 ) . While agronomic practices may

be dependent on the soy

bean maturity

group and variety cultivated, common management strategies are shared across regions. These include management strategies related to tillage, pest management, fertilization, and crop rotation. Tillage The broad adoption of glyphosate - tolerant so yb ean varieties and gl yphosate has influenced several aspects of so yb ean management. In particular, tillage trends have been affected. Prior to planting, the soil must be stripped of weeds that w ould otherwise compete with soy be an for space, water, and light. Tillage represents a mechanical means of weed control and is generall y characterized b y the amount of remaining in - field residue and may be classified as conservation ( > 30 percent), reduced (15 - 30 percent), or intensive (0 - 15 percent) ( CTIC, 2008 ) . Conservation tillage practices b y U.S. soy bean growers increased following the commercialization of gl yphosate - tolerant so yb ean in 1996, totaling 42 pe rcent of soy bean acreage in 2008 ( CTI C, 2008 ; NRC, 2010 ) . Conservation tillage adoption is generall y associated with broad - spectrum herbicide use, due to the capacity of broad - spectrum herbicides to burn down a variety of weed populations prior to planting a crop. Though th e causality between herbicide - tolerant so ybean adoption and conservation tillage may be debated ( Fernandez - Cornejo e t al., 2003 ; Mensah, 2007 ) , most empirical evidence suggests a direct relationship between grower adoption of herbicide - tolerant crops and conservation tillage (NRC, 2010 ) . Fertilization and Crop Rotation Soy beans may remove up to 7 0 pounds of nitrogen from the soil when a 50 - bushel yield of soy bean is attained ( Hoeft et al., 2000 ) . USDA - ERS estimates that less than 40 percent of soy bean acres in the U.S. receive nitrogen fertilizer (USDA - ERS, 2010d) . T he nitrogen requirement of so yb ean is often provided through fertilization of the previous rotation crop or8

through a sy

mbiotic relationship with nodulating bacteria in root tissue ( Ferguson et al., 2012 ) . Given the important role of these bacteria for meeting nitrogen needs of so ybean, commercial sources of nodulating bacteria ino culants can be applied to soy bean seeds just before planting ( Beuerlein, 2005 ) . The benefits of crop rotation in soy bean include i mproved yi eld and pro fitability of one or both crops, d ecreased need for addition al nitrogen on the cro p following soy bean, increased residue cover, mitigation of pest cycles, r educed soil erosion and improved soil quality , or r educed runoff of agricultural inputs ( Al - Kaisi et al., 2003 ) . According to USDA - ERS, 95 percent of the soy bean - planted acreage has been in some form of a crop rotation sy stem since 1991 (USDA ER S, 2011b ) . In a survey of major corn/soy

bean production states, corn and soy bean were alternated on 72 to 80 percent of acreage, other rotations were grown on 16 to 20 percent of acreage, and so ybean was grown continuously on 5 to 12 percent of acreage between 1996 - 2002 ( Sandretto and Pay

ne, 2006 ) . In another anal ys is, the majority of the U.S. soy

bean acreage (68.6 percent ) is rotated to corn ( Monsanto, 2010 ) at page 157 , et seq.). Approximately 14.5 percent of the soy bean acreage is rotated back to soy bean the following year. Other rotational crops that may be planted following soy bean include wheat, cotton, rice, sorghum , barley , oats, and dry beans. Pesticide Use Pest management is an integral part of so yb ean production. However, U.S. soy bean growers generall y face reduced pest pressure from insects, due in large part to the capacity of so ybeans to experience limited in sect herbivory without a reciprocal loss in grain yield ( Penn State Extension, 2011 ) . This recalcitrance to insect damage is evident in the low use of insecticides on cultivated soy

bean acreage; i n 2006, i nsecticides were applied on 16 percent of soy bean acres , with no single insecticide exceeding 6 percent of chemically- treated acreage (USDA - NASS, 2007 ) . Weeds are the most problemat ic pests of so ybean production fields, resulting in a 12 to 80 percent loss in grain yi eld ( Barrentine, 1989 ) . Individual w eed species, including gly phosate resistant species, are discussed in Section 2.3.2 . Soy bean growers may

use a variety of methods to control soy

bean weeds. At present, application of gl yphosate represents the most common weed management s ys tem in U.S. so yb ean fields (Figure 2) . In 2006, 98 percent of soy bean acreage was subject to herbicide application; gl yp hosate was the most - widely applied herbicide on these chemically- treated acres at 92 percent (USDA -NASS, 2007 ) . While total herbicide use trends are subject to debate, it is clea r that an herbicide - substitution effect occurred in U.S. soy bean production ( Benbrook, 2009 ; Fe rnandez - Cornejo et al., 2003 ; Fernandez - Cornejo et al., 2009 ) . Since 1996, gly

phosate use has increased at the expense of alternative herbicides, with respect to total pounds of active ingredient per acre (lbs. ai/acre) applied ( Fernandez - Cornejo et al., 2009 ; NRC, 2010 ) . This statement, however, should not be misinterpreted to mean that the diversity of herbicides available to U.S. soybean growers has decreased; rather, the diversity of herbicides used in U.S. soybean production fields has gradually increased whi le applied quantities of those same herbicides (except glyphosate) have generally decreased ( Figure 3 ). However, it is prudent to note that total herbicide use may not be an effective metric to measure environmental impact, as this does not effectivel y pe rmit the environmental comparison of9

different herbicides across time or across management strategies ( Fernandez - Cornejo et al., 2009 ) .

**Figure 2**  **.** Adoption of GE herbicide - tolerant soy bean and gl yphosate us e on U.S. soy bean fields, 1990

– 2006. GE gl yphosate - tolerant so yb ean was commercialized in 1996. Sources: USDA - ERS (2011a) and USDA -NASS (1991, 1996, 2002, 2007).

**Figure 3**  **.** Extent of gly

phosate use and diversity of herbicide s applied in U.S. soy bean production, 1990

– 2006. Sources: USDA -NASS (1991, 1996, 2002, 2007).10

2.1.3 Organic So ybean Production In the U.S., only

products produced using specific methods and certified under the USDA’s Agricultural Marketing Service (AMS) Nat ional Organic Program (NOP) definition of organic farming can be marketed and labeled as “organic” (USDA - AMS, 2010a) . Organic certification is a process - based certification, not a certification of the end product; the certification proces s specifies and audits the methods and procedures by which the product is produced. In accordance with NOP, an accredited organic certifying agent conducts an annual review of the certified operation’s organic sy stem plan and makes on - site inspections of the certified operation and its records. Organic growers must maintain records to show that production and handling procedures compl y with USDA organic standards. The NOP regulations preclude the use of excluded methods. The NOP provides the following gu idance under 7 CFR Section 205.105: ...to be sold or labeled as “100 percent organic”, “organic” or “made with organic (specified ingredients or group(s)),” the product must be produced and handled without the use of:... (a) S ynthetic substances and ingredient s,... (e) Excluded methods,... Excluded methods are then defined at 7 CFR Section 205.2 as: A variety of methods used to geneticall y modify organisms or influence their growth and development by means that are not possible under natural conditions or processes and are not considered comp atible with organic production. Such methods include cell fusion, microencapsulation and macroencapsulation, and recombinant DNA technology (including gene deletion, gene doubling, introducing a foreign gene, and changing the p ositions of genes when achieved by recombinant DNA technology). Such methods do not include the use of traditional breeding, conjugation, fermentation, h ybridization, in vitro fertilization, or tissue culture. Organic farming operations, as described b y the NOP, are required to have distinct, defined boundaries and buffer zones to prevent unintended contact with excluded methods from adjoining land that is not under organic management. Organic production operations must also develop and maintain an organi c production sy stem plan approved b y their accredited certifying agent. This plan enables the production operation to achieve and document compliance with the National Organic Standards, including the prohibition on the use of excluded methods (USDA AMS, 2010a) . Common practices organic growers may use to exclude GE products include planting onl y organic seed, planting earlier or later than neighboring farmers who may be using GE crops so that the crops will flower at different times, and employing adequate isolation distances between the organic fields and the fields of neighbors to minimize the chance that pollen will be carried between the fields (NCAT, 2003 ) . Although the National Organic Standards prohibit the use of11

excluded methods, they

do not require testing of inputs or products for the presence of excluded methods. The presence of a detectable residue of a product of excluded methods alone does not necessarily

constitute a violation of the National Organic Standards (USDA - AMS, 2010a) . The current NOP regulations do not specify an acceptable threshold level for the adventitious presence of GE materials in an organic - labeled product. The unintentional presence of the products of excluded methods will not affect the status of an organic product or operation when the operation has not used excluded methods and has taken reasonable steps to avoid contact with the products of excluded methods as detailed in their approved organic sy stem plan ( Ronald and Fouce, 2006 ; USDA - AMS, 2010a) . In 2008, the U.S. produced 125,621 acres of NOP certified soy bean ( Figure 4 ).

**Figure 4**  **.** U.S. certified organic so ybean, 2008. Source: USDA - ERS ( 2010c ) . **2.2 Physical Environment**  2.2.1 Soil Quality Cultivation of soy

bean directl y impacts the qualitative and quantitative attributes of soil. For example, conventional tillage and mechanized harvesting machinery may disturb and expose the top soil surface layer, leaving the land prone to degradation. In turn, degradation of soil str ucture and composition may

lead to decreased water retention, a decrease in soil carbon aggregation and net positive carbon sequestration, and increased emission of radiatively- active gases that contribute to the greenhouse effect (e.g., carbon dioxide ( CO 2 ) and nitrous oxide (N 2 O)) ( EPA, 2010d ; Lal and Bruce, 1999a) . Additionally , land that is prone to degradation is also more likely to negatively

affect water resource quality and communities of organisms dependent on those water resources.12

2.2.2 Water Resources So ybean cultivation may directly affect water resources through the use of local water sources or indirectly through associated management practices, including tillage and the use of agricultural inputs. The ty

pical amount of water required for a high - yi e lding so yb ean crop is approximately 20 inches during the growing season ( Hoeft et al., 2000 ) . While normal climatic conditions may provide sufficient water to produce a so yb ean crop, precipitation may vary across states and irrigation may

be needed to supplement precipit ation amounts. Irrigation may also vary from ye ar to year. In general, however, the majority of soy bean acreage in the U.S. is grown with very little supplemental irrigation ( Table C 2, Appendix C) ( The Key stone Center, 2009 ) . In most states, irrigation water comes predominantly from groundwater sources, with comparativel y little derived from surface water sources (USDA - NASS, 2010 ) . Agricultural non - point source (NPS) pollution is the primary source of discharge pollutants to groundwater (aquifers) , flowing water (permanent or intermittent streams), or semi - static water (ponds, lakes, and reservoirs) ( Ramanarayanan et al., 2005 ) . NPS pollutants generall y include agricultural inputs, such as fertilizers or pesticides. A lthough meteorological (e.g., precipitation, temperature), morphological (e.g., land use, soil ty pe), and environmental fate drivers affect water quality, anthropogenic practices (product use and management) are the most relevant, as this driver is general ly

under direct grower control on a soy bean farm ( Ramanarayanan et al., 2005 ) . In particular, tillage practices often have a strong, indirect effect on water quality through the improvement of soil quality and water retention characteristics. Agricultural pollutants released b y soil erosion include sediments, fertilizers, and pesticides that are introduced to area lakes and streams when they are carried off of fields by rain or irrigation waters ( EPA, 2005 ) . 2.2.3 Air Quality Agriculture , including land - use changes for farming, is estimated to be responsible for eight percent of all human - i nduced GHG emissions in the U.S. ( Massey and Ulmer, 2010 ) . Man y agricultural activities affect air quality, including smoke from agricultural burning , machinery , and N 2 O emissions from the use of nitrogen fertilizer ( Aneja et al., 2009 ; EPA, 2010b ; Hoeft et al., 2000 ) . Emissions released from agricultural equipment (e.g., irrigation pumps and tractors) include carbon monoxide, nitrogen oxides, reactive organic gases, particulate matter, and sulfur oxides ( EPA, 2010b ) . Tillage contributes to the release of greenhouse gases (GHG) because of the loss of CO 2 to the atmosphere and the exposure and oxidation of soil organic matter ( Baker et al., 2005b ) . Pesticides may volatilize after application to soil or plant surfaces and move following wind erosion ( Vogel et al., 2008 ) . 2.2.4 Climate Change Climate change represents a statistical change in global climate conditions, including shifts in the frequency of extreme weather ( Cook et al., 2008 ; Karl et al., 2008 ) . Agriculture is recognized as a direct (e.g., exhaust from equipment) and indirect (e.g., agricultural - r elated soil disturbance) source of GHG emissions. Greenhouse g ases, including CO 2 , methane (CH 4 ), and N 2 O , function as retainers of solar radiation ( Aneja et al., 2009 ) . The U.S. agricultural sector is identified as the second largest contributor to GHG emissions ( EPA, 2010a) .13

Agriculture may

also affect dy

namic soil processes through tillage and other land management practices ( Smith and Conen, 2004 ) . In general, conservation tillage strategies are associated with more stable and increased carbon sequestration due to a net reduction in carbon dioxide emissions ( Lal and Bruce, 1999b ; West and Marland, 2002 ) . Recent literature, however, suggests that the relationship between conservation tillage and increased carbon sequestration require more study , as soil depth level and seasonal sampling bias may inadvertently affect measurements ( Baker et al., 2007 ; Potter et al., 1998 ) . Additionally , the relationship between different GHG emissions, such as carbon dioxide and nitrous oxide may influence paradigms related to tillage strategies and global climate change ( Gregorich et al., 2005 ) . For example, increased nitrous oxide emissions as a result of conservation tillage strategies may offset any gains achieved through increased c arbon sequestration. L ike the relationship between conservation tillage strategies and carbon sequestration, a broad generalization regarding the impact of tillage strategy

and nitrous oxide emissions is difficult, as numerous factors influence soil nitri fication cycles, including geographic location, soil structure, moisture, and farm - level management practices ( Grandy et al., 2006 ; Gregorich et al., 2006 ; Rochette et al., 2008 ) . Global climate change may also affect agricultural crop production ( CCSP, 2008 ) . These potential impacts on the agro - environment and individual crops may be direct, includin g changing patterns in precipitation, temperature, and duration of growing season, or may cause indirect impacts influencing weed and pest pressure ( Rosenzwe iget al., 2001 ; Schmidhuber and Tubiello, 2007 ) . The impacts of GE crop varieties on climate change are unclear, though it is likely dependent on cropping s ys tems, production practices, geogra phic distribution of activities, and individual grower decisions. APHI S will continue to monitor developments that may lead to possible changes in the ty pical production s ys tem likely to result from GE products brought to APHI S for a determination of nonr egulated status. The potential impact of climate change on agricultural output, however, has been examined in more detail. A recent Intergovernmental Panel on Climate Change ( IP CC ) forecast ( 2007 ) for aggregate North American impacts on agriculture from climate change actuall y projects yield increases of 5 to 20 percent for this century . The IP CC report notes that certain regions of the U.S. will be more heavil y impact ed because water resources may be substantially

reduced. While agricultural impacts on existing crops may

be substantial , North American production is expected to adapt with improved cultivars and responsive farm management ( IPPC, 2007 ) . **2.3 Biological Resources**  2.3.1 Animal Communities Wildlife may

be found within or near soy bean fields. Deer and groundhogs feed on so ybean and cause so ybean damage, while feeding damage from Eastern cottontail , rac coon, squirrels, and other rodents is of less importance ( MacGowan et al., 2006 ) . Additionally, m igratory birds may feed on spilled so ybean following harvest ( Galle et al., 2009 ; Gamble et al., 2002 ) . Crop pest insects are considered les s problematic than weeds in U.S. soy bean production; nevertheless, insect injury can impact yi eld, plant maturity , and seed quality . A variety of insect pests may be found in U.S. soy

bean fields, including those that feed on reproductive tis sue, foliage, and roots/nodules (Table C3, Appendix C ) . Insect pests are managed during the growth14

and development of so yb ean to enhance so ybean yield ( Aref and Pike ; Higley and Boethel, 1994 ) , with 16 perce nt of soy bean acreage treated with insecticides (USDA -NASS, 2007 ) . 2.3.2 Plant Communities The vegetative landscape surrounding a so ybean field varies with region; soybean fields may be surrounded b y additional soy bean varieties, other crops, or woodland/pasture/ grassland areas. W eeds are perceived to be the most substantial pest problem in soy bean production , negativel y affecting yi eld through competition for light, nutrients, and moisture ( Aref and Pike, 1998 ) . When weeds are left to compete with soy bean for the entire growing season, yield losses can exceed 75 percent ( Dalley et al ., 2001 ) . Eighty- six common weeds of soybean across three growing regions have been identified (Tables B4 - B6, Appendix B). Weed populations can change in response to agricultural management decisions, including decisions related to herbicide appli cation. Weeds can develop resistance to herbicides for the following reasons: frequent exposure to a single herbicide, the spread of naturally- resistant weeds seeds, and the out - crossing of herbicide - tolerant genes from plants (GE or naturall y resistant p lants) to weedy relatives. The development of herbicide resistance in weeds is not unique to any

one country

(Figure C1, Appendix C ) , particular herbicide (Figure C2, Appendix C ) , or crop variety. In the U.S., 76 weed species have developed resistance to at least 17 herbicide MoAs ( Heap, 20 11a) . Currentl y, nine glyphosate - resistant weeds have been identified in U.S. soy

bean fields (Figure 5 ), inhabiting approximately two million acres of farmland in the U.S. ( Hubbard, 2008 ) .

**Figure 5**  **.** Gl yphosate - resistant weeds in the U.S. soy bean fields. Note that presence of a population is unrelated to prevalence. * indicates at least one population in that states possesses resistance to gl yphosate and another herbicide. **indicates at least one population in that state possesses resistance to glyphosate and two other herbicides. Source: Heap ( 2011a) .15

2.3.3 Gene Flow and Weediness Gene flow is a biological process that facilitates the production of hybrid plants, introgression of novel alleles, and evolution of new plant genotypes. Gene flow to and from an agro - ecos ys tem can occur on both spatial and temporal scales. In general, plant pollen tends to represent the major reproductive method for mov ing across areas, while both seed and v egetative propagation tend to promote the movement of genes across time and space. The rate and success of gene flow is dependent on numerous factors . General factors related to pollen - mediated gene flow include the presence, abundance, and distance of sexually- compatible plant species; overlap of flowering phenology between populations; the method of pollination; the biology

and amount of pollen produced; or weather conditions, including temperature, wind, and humidity ( Zapiola et al., 2008 ) . Seed - mediated gene flow also depends on many factors, including the absence, presence, and magnitude of seed dormancy ; contribution and participatio n in various dispersal pathway s; or environmental con ditions and events ( Zapiola et al., 2008 ) . Soy bean is not native to the U.S. and there are no feral or weedy relatives. Consequently , soy bean in the U.S. can cross only with other so yb ean varie ties. Additionally , p otential of soy bean weediness is low , due to domestication syndrome traits that generally lower overall fitness outside an agricultural environment ( Stewart et al., 2003 ) . Mature soy bean seeds have no innate dormancy , are sensitive to cold, and are not expected to survive in freezing winter condition s ( Raper and Kramer, 1987 ) . 2.3.4 Microorganisms Microorganisms in the field may mediate both negative and positive outcomes. Various bacterial and fungal species have been identified as the causal agents of various diseases afflicting soy bean plants ( Ruhl, 2012 ) . Additionally , s oil microorganisms may play a key role in dy

namic biochemical soil processes ( Garbeva et al., 2004 ) . They may also suppress soil - borne plant diseases and promote plant growth ( Doran et al., 1996 ) . The main factors affecting microbial population size and diversity include soil ty

pe, plant ty

pe, and agricultural management practices ( Garbeva et al., 2004 ) . Microbial diversity in the rhizosphere may

be extensive and differ from the microbial community in the bulk soil ( Garbeva et al., 2004 ) . 2.3.5 Biodiversity Biodiversity

refers to all plants, animals, and microorganisms interacting in an ecos ys tem ( Wilson, 1988 ) . Biodiversity provides valuable genetic resources for crop improvement and also provides other functions beyond food, fiber, fuel, and income ( Harlan, 1975 ) . These include pollination, genetic introgression, biological control, nutrient recycling, competition against natural enemies, soil structure, soil and water conservation, disease suppression, control of local microclimate, control of local h ydrological processes, and detoxification of noxious chemicals ( Altieri, 1999 ) . The loss of biodiversity results in a need for costl y management practices in order to provide these functions to the crop ( Altieri, 1999 ) . The degree of biodiversity in an agroecos ys tem depends on four primary characteristics: 1) diversity of vegetation with in and around the agroecos ys tem, 2 ) permanence of various crops16

within the sy stem, 3) intensity of management, and 4) extent of isolation of the agroecos ys tem from natural vegetation ( Southwood and Way , 1970 ) . Agricultural land subject to intensive farmin g practices, such as that used in crop production, generall y has low levels of biodiversity compared with adjacent natural areas. Tillage, seed bed preparation, planting of a monoculture crop, pesticide use, fertilizer use, and harvest result limit the di versity

of plants and animals ( Lo vett et al., 2003 ) . Since biological diversity can be defined and measured in many ways , APHIS considers determini ng the level of biological diversity in any crop to be complex and difficult to achieve concurrence. Another complication with biodiversity studies is separating expected impacts from indirect impacts. For example, reductions of biological control organi sms are seen in some Bt - expressing GE crops, but are caused b y reduction of the pest host population following transgenic pesticide expression in the transformed crop plant. **2.4 Human Health**  Public health concerns surrounding GE so ybean primarily involve the human consumption of GE soy bean products. Additionally , soy bean growers and farm workers may also be exposed to GE soy bean and its respective cultivation practices. Under the FFDCA, it is the responsibility of food manufacturers to ensure that the produc ts they market are safe and properly labeled. Food derived from GE so ybean must be in compliance with all applicable legal and regulatory requirements. GE organisms for food may undergo a voluntary consultation process with the FDA prior to release onto the market. Although a voluntary process, thus far , all applicants who wish to commercialize a GE variety that will be included in the food supply have completed a consultation with the FDA. Worker hazards in farming are common to all typ es of agricultural production, and include hazards of equipment and plant materials. Pesticide application represents the primary exposure route to pesticides for farm workers (USDA -NASS, 2007 ) . However, c ommon farm practices , training , and specialized equipment can mitigate exposure to pesticides by farm workers ( Baker et al., 2005a) . For example, c hoosing from less toxic groups of insecticides to control soy bean insects is a good common agricultural practice. Agricultural pesticide exposure levels are regulated by EPA labels. EPA’s Worker Protection Standard (WPS) (40 CFR part 170) was published in 1992 requiring actions to re duce the risk of pesticide poisonings and injuries among agricultural workers and pesticide handlers. The WPS offers protection to more than two and a half million agricultural workers who work with pesticides at more than 560,000 workplaces on farms, forests, nurseries, and greenhouses. The WPS contains requirements for pesticide safety training, notification of pesticide applications, use of personal protective equipment, restricted entry intervals following pesticide application, decontamination suppli es, and emergency medical assistance.17

**2.5 Animal Feed**  Animal feed concerns surrounding GE so ybean primarily involve the animal consumption of GE soy bean products. Soy

bean meal is a substantial part of animal feed rations in the U . S. In 2009, approximately

3 9 million tons of soy

bean meal were produced, 27 million tons of which were marketed for animal feed, with the largest volumes consumed by poultry (48 percent), swine (26 percent), and beef (12 percent) ( Soy Stats, 2010 ) . Similar to the regulatory

control for direct consumption of soy bean under the FFDCA, it is the responsibility

of feed manufacturers to ensure that the products they market are safe and properl y labeled. Feed derived from GE soy bean must comply

with all applicable legal and regulatory requirements, which are designed to protect human health. To help ensure compliance, a voluntary consultation process with FDA may be implemented before release of GE plants in animal feed i nto the market . **2.6 Socioeconomic**  2.6.1 Domestic Economic Environment The domestic soy

bean industry

is primaril y composed of commodity production businesses and the users of so ybean products (Figure 6 ). A more detailed description of the domestic soy bean industry is presented in Appendix C. In 2010 , 76 million acres of soy beans were cultivated in the U.S., yielding 3.3 billion bushels at a value of 38.9 billion U.S. dollars (USDA -NASS, 2011c ) . Total 2010 U.S. inventory (2009 remaining stocks plus 2010 production) totaled 3.5 billion bushels, with 43 percent of U.S . soy bean destined for the export market (USDA - ERS, 2010b ) . The remaining 57 percent of U.S. soy bean inventory

was primarily

utilized to produce soy

bean meal for feed, with lesser amounts processed for so ybean oil for industrial or consumption purposes; seed and residuals; or ending stock for storage (Figure 7 ) . The majority of so yb ean in the U.S. is used to produce animal feed or secondary

industrial products, wi th only a small proportion of the soy bean crop being consumed directl y b y humans ( GI NA, 2011 ) . Soy m eal typicall y contains about 50 percent protein by dry weight, and is the most important product of so ybean production. Of the domestically crushed soy

bean, 53 percent of soy

bean by weight produces meal and 19 percent produces oil (USB, 2011 ) . Changes in fatty acid profile may impact food and industrial uses of the soy bean oil. Fatty

acid composition of the soy bean oil affects melting point, oxidative stability , and chemical functionality, and changes in an y of these can impact the market sect or of the product ( APAG, 2011 ) . These fatty acid properties influence the market applications for the oil, and various foods and industrial products are formulated to take these properties into consid eration ( Cahoon, 2003 ; Cargill, 2011 ; Soy Co nnection, 2011 ) .18

**Figure 6**  **.** General flow of U.S. soy bean commodities. Size of directional arrows is approximately

proportional to use. For example, bold arrows represent the primary path of soy bean commodities, whereas da shed arrows represent paths of so yb ean use that are relativel y minor. Businesses are boxed in gray , while commodities are unboxed.

**Figure 7**  **.** U.S. inventory and use of harvested so ybeans, 2010. Source: USDA - ERS (2010b).19

2.6.2 Trade Economic Environment The U.S. produces approximately 35 percent of the global soy bean suppl y ( Soy

Stats, 2011c ) . In 2010, the U.S. exported 1.6 billion bushels of soy bean, which accounted for 44 percent of the world's so yb ean exports ( Soy Stats, 2011b ) . In total, the U.S. e xported $18.6 billion worth of soy bean and so ybean products globall y in 2010 ( Soy Stats, 2011a) . China is the largest export market for U.S. so ybean with purchases totaling $10.8 billion. Mexico is the second largest export market with sales of $1.5 bil lion in the same year (Table 2 ). Other important markets include Japan and the EU. **Table 2**  **.** U.S. export markets for so ybean and so ybean products. Values of exports are listed in millions of dollars. Top Ten U.S. Export Customers 2010

Soybean Exports Soybean Meal Exports Soybean Oil Exports China+Hong Kong 10,823 Canada 354 China+Hong Kong 420 Mexico 1,495 Mexico 344 Mexico 200 Japan 1,127 Philippines 256 Morocco 198 Indonesia 806 Venezuela 217 India 133 Taiwan 653 Morocco 164 Peru 76 Germany 502 Dominican Republic 145 Algeria 71 Egypt 411 Japan 126 Domican Republic 56 Spain 349 Vietnam 116 Canada 47 South Korea 312 Guatemala 106 Venezuela 43 Turkey 250 Poland 100 Nicaragua 36 Other 1,858 Other 1,174 Other 290 Total 18,586 Total 3,103 Total 1,569 Source: Soy Stats ( 2011a) .20

**3 ALTERNATIVES**  This document anal yz es the potential environmental consequences of a determination of nonregulated status of FG72 soy bean. To respond favorabl y to a petition for nonregulated status, APHI S must determine that FG72 is unlikely to pose a plant pest risk. APHI S has conclu ded through a PPRA that FG72 soy bean is unlikely

to pose a plant pest risk (USDA - APHI S, 2012b ) . Therefore, APHI S must determine that FG72 soybean is no longer subject to 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. Two alternatives are evaluated in this EA: ( 1) No A ction : Continuation as a Regulated Article and (2) Preferred Alternative: D etermination that FG72 Soy bean is No Longer a Regulated Article . APHIS has assessed the potential for environmental impacts for each alternative in the Environmental Conseque nces section. **3.1 No Action Alternative: Continuation as a Regulated Article**  Under the No Action Alternative, APHIS would deny the petition. FG72 soy

bean and progen y derived from FG72 would continue to be regulated articles under the regulations at 7 CFR p art 340 . Permits issued or notifications acknowledged by APHIS would still be required for introductions of FG72 soy bean and measures to ensure ph ys ical and reproductive confinement would continue to be implemented. APHIS might choose this alternative if th ere were insufficient evidence to demonstrate the lack of plant pest risk from the unconfined cultivation of FG72 so ybean . This alternative is not the Preferred Alternative because APHIS has concluded through a PPRA that FG72 so ybean is unlikely to pose a plant pest risk (USDA - APHIS, 2012 b ) . Choosing this alternative would not satisfy the purpose and need of making a determination of plant pest risk status and responding to the petition seeking nonregulated status. **3.2 Preferred Alternative: Determination that FG72 Soybean is No Longer a R** **egulated Article**  Under this alternative, FG72 soy bean and progeny

would no longer be regulated articles under the regulations at 7 CFR part 340 . FG72 so yb ean is unlikely to pose a plant pest risk (USDA APHI S, 2012b ) . Permits issued or notifications acknowledged by APHIS would no longer be required for introductions of FG72 so ybean and progen y derived from this event . This alternative best meets the purpose and need to respond appropriatel y to a petition seeking nonregulated status based on the requirements in 7 CFR part 340 and the agen cy ’s authority under the plant pest provisions of the Plant Protection Act. Because the agency has concluded that FG72 so ybean is unlikely to pose a plant pest risk, a determination of nonregulated status of FG72 so ybean is a response that is consistent wi th the plant pest provisions of the Plant Protection Act , the regulations codified in 7 CFR part 340, and the biotechnology regulatory policies in the Coordinated Framework. Under this alternative, growers may have future access to FG72 soy bean and progen y derived from this event if the developer decides to commercialize FG72 so ybean .21

**3.3 Alternatives Considered But Rejected from Further Consideration**  APHI S assembled a list of alternatives that might be considered for FG72 soy bean . The agency evaluated these alternatives with respect to the agency's authority under the plant pest provisions of the Plant Protection Act, and the regulations at 7 CFR part 340, with respect to environmental safety, efficacy , and practicality to identify

which alternatives would be further considered for FG72 so ybean . Based on this evaluation, APHI S rejected several alternatives. These alternatives are discussed briefl y below along with the specific reasons for rejecting each. 3.3.1 Prohibit Any

FG72 So yb ean from Being Released In respon se to public comments that stated a preference that no GE organisms enter the marketplace, APHIS considered prohibiting the release of FG72 so ybean , including den yi ng any permits associated with the field testing. APHI S determined that this alternative is not appropriate given that APHI S has concluded that FG72 so ybean is unlikely to pose a plant pest risk (USDA - APHIS, 2012b ) . In enacting the Plant Protection Act, Congress found that [D]ecisions affecting imports, exports, and interstate movement of products regulated under [the Plant Protection Act] shall be based on sound science...§ 402(4). On March 11, 2011, in a Memorandum for the Heads of Executive Departments and Agencies, the White House Emerging Technologies Interagency Policy Coordination Committee developed broad principles, cons istent with Executive Order 13563, to guide the development and implementation of policies for oversight of emerging technologies (such as genetic engineering) at the agency

level. In accordance with this memorandum, agencies should adhere to Executive Order 13563 and, consistent with that Executive Order, the following principle, among others, to the extent permitted by

law, when regulating emerging technologies: “[D]ecisions should be based on the best reasonably obtainable scientific, technical, econom ic, and other information, within the boundaries of the authorities and mandates of each agency” Based on the PPRA (USDA - APHIS, 2012b ) and the scientific data evaluated therein, APHIS concluded that FG72 so ybean is unlikely to pose a plant pest risk. Accordingl y, there is no basis in sc ience for prohibiting the release of FG72 so ybean . 3.3.2 Approve the Petition in Part The regulations at 7 CFR 340.6(d)(3)(i) state that APHI S may "approve the petition in whole or in part." For example, a determination of nonregulated status in part may be app ropriate if there is a plant pest risk associated with some, but not all lines described in a petition. Because APHIS has concluded that FG72 soy bean is unlikely

to pose a plant pest risk, there is no regulatory basis under the plant pest provisions of th e Plant Protection Act for considering approval of the petition only

in part.22

3.3.3 Isolation Distance between FG72 and Non - GE Soy bean Production and Geographical Restrictions In response to public concerns of gene movement between GE and non - GE plants, APHI S co nsidered requiring an isolation distance separating FG72 from non - GE soy bean production. However, because APHIS has concluded that FG72 soy bean is unlikely

to pose a plant pest risk (USDA - APHIS, 2012b ) , an alternative based on requiring isolation distances would be inconsistent with the s tatutory authority under the plant pest provisions of the Plant Protection Act and regulations in 7 CFR part 340. APHI S also considered geographically restricting the production of FG72 soy bean based on the location of production of non - GE soy bean in organic production sy stems or production s ys tems for GE - sensitive markets in response to public concerns regarding possible gene movement between GE and non - GE plants. However, as presented in APHI S’ PPRA for FG72 so yb ean, there are no geographic differences associated with any identifiable plant pest risks for FG72 soy bean (USDA - APHIS, 2012b ) . This alternative was rejected and not analy zed in detail because APHI S has concluded that FG72 soy bean does not pose a plant pest risk, and will not exhibit a greater plant pest risk in any geographic ally

restricted area. Therefore, such an alternative would not be consistent with APHI S’ statutory authority under the plant pest provisions of the Plant Protection Act and regulations in Part 340 and the biotechnology regulatory

policies embodied in the Coordinated Framework. Based on the foregoing, the imposition of isolation distances or geographic restrictions would not meet APHI S’ purpose and need to respond appropriately to a petition for nonregulated status based on the requirements in 7 CFR part 34 0 and the agency ’s authority under the plant pest provisions of the Plant Protection Act. However, i ndividuals might choose on their own to geographically

isolate their non - GE soy

bean production sy stems from FG72 soy bean or to use isolation distances and other management practices to minimize gene movement between soy bean fields . In formation to assist growers in making informed management decisions for FG72 soy bean is available from the Association of Official Seed Certifying Agencies ( AOSCA, 2010 ) . 3.3.4 Requirement of Testing for FG72 So ybean During the comment periods for other petitions for nonregulated status, some commenters requested USDA to require and provide testing for GE products in non - G E production sy stems. APHI S notes there are no nationally - established regulations involving testing, criteria, or limits of GE material in non - GE sy stems. Such a requirement would be extremely difficult to implement and maintain. Additionally , because F G72 soy bean does not pose a plant pest risk (USDA - APHIS, 2012b ) , the imposition of any t yp e of testing requirements is inconsistent with the plant pest provisions of the Plant Protection Act, the regulations at 7 CFR part 340 and biotechnology

regulatory policies embodied in the Coordinat ed Framework. Therefore, imposing such a requirement for FG72 so yb ean would not meet APHI S’ purpose and need to respond appropriatel y to the petition in accordance with its regulatory authorities.23

**3.4 Comparison of Alternatives**  Table 3 presents a summary of the potential impacts associated with selection of either of the alternatives evaluated in this EA. The impact assessment is presented in Section 4 of this EA. **Table 3**  **.** Summary

of issues of potential impacts and consequences of alt ernatives. **Attribute/Measure Alternative A: No Action**  **Alternative B: Determination of**  **Nonregulated Status Meets Purpose and Need**  **and Objectives No**  **Yes** Unlikely to pose a plant pest risk Satisfied through use of regulated field trials Satisfied

– risk ass essment ( USDA - APHIS, 2012b ) **Mana gement Practices**  Acreage and range of soybean p roduction No No Agronomic p ractices No No Pesticide u se No No Organic soybean p roduction No No **Environment** Soil quality No No Water resources No No Air quality No No Climate c hange No No Anima l communities No No Plant communitie s No No Gene flow/weediness No No24

**Attribute/Measure Alternative A: No Action**  **Alternative B: Determination of**  **Nonregulated Status** Soil microorganisms No No Biodiversity No No **Human and Animal Health** Human/worker h ealth No No Livestock health/animal f eed No No **Socioeconomic** Domestic economic e nvironment No No Trade e conomic e nvironment No No **Other Regulatory Approvals** U.S. Non - com pleted FDA consultation Non - com pleted FDA consultation **Compliance with Other Laws** CWA, CAA, Eos Fully compliant Fully compliant25

**4 ENVIRONMENTAL CONSEQ**  **UENC ES**  This analy sis of potential environmental consequences addresses the potential impact to the human environment from the alternatives anal yz ed in this EA . Potential environmental impacts from the No Action Alternative and the Preferred Alternative for FG 72 soy bean are described in detail throughout this section. Certain aspects of this product and its cultivation would be no different between the alternatives: those instances are described below. A cumulative effects analy sis is also included for each res ource area in Section 5 . A cumulative impact may

be an effect on the environment which results from the incremental impact of the proposed action when added to other past, present, and reasonabl y foreseeable future actions. Examples include breeding FG72 soy bean with other events no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. If there are no direct or indirect impacts identified for a resource area, then there can be no cumulative impacts. **4.1 Scope of Analysis**  Under the No Action Alternative, FG72 so ybean will remain subject to the regulatory requirements of 7 CFR part 340 (Section 3.1); additionally , under the Preferred Alternative, FG72 so ybean will no longer be subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act (Section 3.2). Potential environmental impacts from the No Action Alternative and the Preferred Alternative for FG72 so yb ean are described in detail throughout this section. An impact would be an y change, positive or negative, from the existing (baseline) conditions of the affected environment (described for each resource area in Section 2.0). Impacts may be categorized as direct, indirect, or cumulative. A direct impact is an effect that results solely from a proposed action without intermediate steps or processes. Examples include soil disturbance, air emissions, and water use. An indirect impact may

be an effect that is related to but removed from a propo sed action b y an intermediate step or process. Examples include surface water quality changes resulting from soil erosion due to increased tillage, and worker safety impacts resulting from an increase in herbicide use. Where it is not possible to quanti fy impacts, APHIS provides a qualitative assessment of potential impacts. Certain aspects of this product and its cultivation may be no different between the alternatives; those are described below. Although the Preferre d A lternative would allow for new plantings of FG72 soybean to occur anywhere in the U.S., APHIS will primarily focus the environmental analysis to those areas that currently support soy

bean production. To determine areas of soy bean production, APHIS used data from USDA -NASS and USDA - ERS.26

**4.2 Agricultural Production of Soybean**  4.2.1 Acreage and Range of Soy bean Production No Action Alternative: Acreage and Range of Soybean Production Continued domestic and international demand for soy bean products, coupled with relatively high soy bean commodity

prices, is likely

to continue increasing ( USDA - ERS, 2010b , 2011c ) under the No Action Alternative. In response, total U.S. soy bean acreage is anticipated to incrementall y increase f

rom 76.6 million acres in 2010 to 79.5 million acres in 2020, based on soy bean production trends and projections (USDA - ERS, 2011c ) . In order to accommodate this increase of U.S. so ybean acreage in s pite of a net decrease in available U.S. agricultural land ( EIA, 2007 ) , growers are likely to plant additional soy

bean acreage at the expense of other crops, such as cotton or hay ( O'Brian, 2010 ; USDA - ERS, 2011e ) . The use of existing agricultural land in lieu of previously

uncultivated land for additional soy bean acreage is a necessary land - use decision, as so y

bean is profitably

grown on high quality

arable land, not land of lower productivity ( EIA, 2007 ; USDA -NASS, 2011c ) . Preferred Alternative: Acreage and Range of So ybean Production A determination of a nonregulated status of FG72 soy bean is un likely

to substantially

expand soy bean acreage beyond the projected increases ( USDA - ERS, 2011c ) described in the No Action Alternative for two major reasons. First, FG72 soybean is unlikely to disr upt the causal relationship between market forces and U.S. so ybean acreage, which is ultimately affected b y growing domestic and international demand for soybean commodity products, such as animal feed or industrial oils/plastics (USDA - ER S, 2010b , 2011c ) . Secondl y, FG72 soy bean is unlikely to expand soy

bean acreage beyond projected values (USDA - ERS, 2011c ) because it requires similar management conditions as conventional soy bean, does not present any absolute yield gains over conventional soy bean varieties under typical management conditions, and exhibits no phenoty pe that would be indicative of an improved capacity to grow outside an agricultural environment ( Bayer, 2011c ; USDA - APHIS, 2012 b ) . Similar to currentl y available soybean varieties, FG72 so ybean will likely require cultivation on high quality arable land to produce a grower profit, precluding the use of lower quality , uncultivated land to supply additional soy

bean acreage. FG72 soy

bean is unlikely

to be cultivated on land not previously used for agriculture, thus maintaining observed farm - level land - use decisions to shift agricultural land away from other crops, such as cotton or hay , toward so yb ean production to satisfy market demand ( U SDA ERS, 2010e , 2011c ) . 4.2.2 Agronomic Practices No Action Alternative: Tillage The current trend of increasing conservation tillage adoption is unlikely to change under the No Action Alternative, due t o the extensive market penetration of gl yphosate - tolerant soy bean varieties ( Dill, 2005 ; Owen, 2010 ) and its relationship with conservation tillage practices ( Bonn y, 2011 ; Givens et al ., 2009 ; USDA - ERS, 2010a) . Conservation tillage adoption rates by U.S. soy bean growers are likely

to be sustained by

the continued use of gly

phosate as a broad -27

spectrum herbicide ( Carpenter and Gianessi, 1999 ) that enable conservation tillage strategies to be undertaken as an economical alternative to conventional tillage ( Givens et al., 2009 ; USDA ERS, 2010a) . In the presence of gly

phosate - resistant weeds, some U.S. soy bean growers may

reincorporate the use of conventional tillage practices to manage those problematic weed populations (NRC, 2010 ) . However, in sp ite of increasing concern with gl yphosate - resistant weed populations, the majority of U.S. growers are likel y to continue using gl yphosate at increased rates/frequencies rather than reincorporate conventional tillage into their weed management strategies. This response is due to several reasons, though the most relevant include the substantial costs of conventional tillage (USDA -NRCS, 2011 ) , grower familiarity with gl yphosate ( Johnson et al., 2009 ; NRC, 2010 ; Owen et al., 2011 ) , and the overall value placed on simplicity and c onvenience that is provided by gl yphosate - tolerant sy stems ( Owen, 2010 ) . These reasons, coupled with the extent of gl yphosate - resistant weeds in U.S. soy bean fields (at least 3 percent of U.S. soy bean acreage) ( Owen, 2010 ) , suggest that the continued use of conservation tillage is likely to continue as practiced under the No Action A lternative. Preferred Alternative: Tillage Effective broad - spectrum herbicide use is generally associated with the adoption of conservation tillage in U.S. soy

bean production practices (NRC, 2010 ) . Similar to the No Action Alternative, FG72 so ybean permits the continued use of an existi ng broad - spectrum herbicide (gly phosate) that contributed to the general use of conservation tillage in U.S. production fields; additionally , FG72 so ybean will permit the use of another broad - spectrum herbicide, IFT. The presence of the gl yphosate - tolerant phenoty pe in FG72 soy

bean will permit the continued use of gly phosate as it is used presentl y in conventional U.S. soybean production, maintaining current trends of conservation tillage ( Bonny , 2011 ; Owen, 2010 ; Owen et al., 2011 ) . Concurrentl y, FG72 soy bean will also permit the use of IFT, another effectiv e broad - spectrum herbicide that will permit the continued use of conservation tillage in U.S. soy bean production fields ( Bayer, 2011a , 2011b ) . Thus, there is no reason to suspect that a determination of nonregulated status of FG72 soy bean would alter the shift toward conservation tillage in soy bean, as FG72 soy

bean will represent another herbicide - tolerant so ybean variety that may facilitate the use of conservation tillage ( AOSCA, 2011 ) . No Action Alternative: Fertilization and Crop Rotation Compared to other crop plants, soy bean cultivation requi res less nitrogen fertilization. USDA ERS estimates that less than 40 percent of so ybean acres in the U . S . receive nitrogen fertilizer (USDA - ERS, 2010d) ; this trend of percent so ybean acreage treated with nitrogen fertilizer, along with application rates of nitrogen fertilizer, have remained relatively constant since 1992. Under the No Action Alternative, current trends related to fertilizer use in U.S. soybean production are not anticipated to substantially c hange. According to USDA - ERS, 95 percent of the so yb ean - planted acreage has been in some form of a crop rotation s ys tem since 1991 (USDA - ERS, 2011b ) . Continuous (i.e., non - rotation) so ybean production is discouraged by most extension soy

bean specialists to reduce the risk of diseases and nematodes ( Al - Kaisi et al., 2003 ) . In a survey of major corn/so ybean production states, corn28

and soy bean were alternated on 72 to 80 percent of acreage, other rotations were grown on 16 to 20 percent of acreage, and soy bean was grown continuously on 5 to 12 percent of acreage during the ye ars 1996

– 200 2 ( Sandretto and Pay ne, 2006 ) . Under the No Action Alternative, current trends related to soy bean rotation are unlikely to subst antiall y change. Preferred Alternative: Fertilization and Crop Rotation Similar to the No Action Alternative, a determination of nonregulated status of FG72 so ybean is unlikely to substantially

change fertilization patterns in U.S. soy bean production. Standard agricultural practices are required for the cultivation of FG72 so ybean, demonstrating that it requires typical quantities of nitrogen in the soil ( Baye r, 2011c ) . In general, GE herbicide tolerant soy

bean varieties have not required more supplemental nitrogen fertilization compared to other soy

bean varieties, despite the increase in GE soy bean variety adoption (Figure 8). Additionally , similar to the No Action Alternative, a determination of nonregulated status of FG72 so ybean is unlikely to substantially change current patterns of so ybean crop rotation because it exhibits similar agronomic performance relative to its nontransgenic parent variety, Jack ( Baye r, 2011c ) . In particular , no differences in phy topathology

were generall y observed between FG72 and its nontransgenic parent variety (Jack) in experimental plots (USDA - APHI S, 2012b ) . These similar measures of disease susceptibility suggest that FG72 soy

bean would benefit from currentl y - practiced soy bean rotatio n strategies. Furthermore, cultivation of FG72 soy bean and potential corresponding IFT use may not restrict common corn/soy bean rotation, as the rotation interval for corn following IFT use is 0 months ( Baye r, 2011b ) . Due to this general benefit from crop rotational strategy o n disease mitigation and an unlikel y disruption with common soy

bean rotational crops, a determination of nonregulated status of FG72 soy bean is likely to continue current patterns of rotation in U.S. soy bean production.

**Figure 8**  **.** Percent and application rate of nitrogen fertilization in U.S. soy bean production, 1992

– 2006. Source: USDA - ERS ( 2011f , 2011g ) .29

No Action Alternative: Pesticide Use Under the No Action Alternative, pesticide use in U.S. soy bean fields will likely

continue as it is currentl y practiced. Insecticide application in so ybean, though variab le between states, will likely continue to be restricted to a small percentage of soy bean acres (USDA -NASS, 2002 , 2007 ) , due in large p art to the capacity of soy bean to experience limited insect herbivory without a reciprocal loss in grain yield ( Penn State Extension, 2011 ) . With regard to weed management practices, U.S. soy bean growers will continue to have access to herbicide - tolerant soybean varieties that are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act . U.S. soybean growers will likely continue utilizing herbicides, primarily in the form of glyphosate, as the basis of a weed management system due to the extensive adoption of glyphosate - tolerant soybean varieties ( Carpenter and Gianessi, 1999 ; Fernandez - Cornejo and Mc Bride, 2000 ) and grower preference for the familiarity and convenience of glyphosate -tolerant soybean systems (USDA - ERS, 2011a) . Since the introduction of glyphosate - tolerant soybean varieties, glyphosate application has increased at the expense of alternative herbicides, with respect to total pounds of active ingredient applied ( Fernandez - Cornejo et al., 2009 ) . This statement, however, should not be misinterpreted to mean that the diversity of herbicides available to U.S. soybean growers has decreased; rather, the diversity of herbicides used in U.S. soybean production fields has gradually increased while applied quantities of those same herbicides (except glyphosate) have generally decreased (

NRC, 2010 ; USDA -NASS, 1996 , 2002 , 2007 ) . The increasing frequency of glyphosate - resistant weeds in some soybean production fields may decrease the technical efficacy of glypho sate in controlling weeds. In spite of this, some U.S. soybean growers are hesitant to stop using glyphosate due to familiarity and comfort with the glyphosate - tolerant soybean system. For example, a survey of 400 corn, cotton, and soy bean growers found that a majority would not restrict their use of gl yphosate - tolerant crops [or gl yphosate] when facing increased weed pressure from gl yphosate - resistant weed populations ( Scott and VanGesse l, 2007 ) . Similarly , Delaware soy bean growers continued planting and cultivating gl yphosate - tolerant soy bean varieties in the presence of gl yphosate - resistant horseweed ( Scott and VanGe ssel, 2007 ) . U.S. soy bean growers, however, are beginning to understand that a diversification of selection pressure in their weed management strategies may be necessary to manage and slow gl yphosate resistant weed development ( Johnson et al., 2009 ; NRC, 2010 ; Owen et al., 2011 ) . One general farm - level response to gly phosate - resistant weeds has been to increase the rate/frequency of gl yphosate application and incorporate the use of different herbicidal chemistries ( NRC, 2010 ) . A possible consequence of this action may be an absolute increase in total herbicide use (lbs. ai/acre) in U.S . soybean production ( NRC, 2010 ; Owen, 2010 ) . It is prudent to mention, however, that total herbicide use may not be an effective metric to measure environmental impact, as this does not effectivel y permit the environmental comparison of different herbicides acros s time or across management strategies ( Fernandez - Cornejo et al., 2009 ) .30

Preferred Alternative: Pesticide Use General trends related to soy bean pest management are unlikel y to change under the Preferred Alternative. Insecticide app lication practices are likely to be similar between FG72 so yb ean and conventional soy

bean, as FG72 soy

bean is not more susceptible to insect herbivory than conventional soy

bean varieties (USDA - APHIS, 2012b ) . Herbicide use trends in U.S. soy bean production are not anticipated to be substantially affected following a determination of nonregulated status of FG72 so ybean. FG72 soy bean is tolerant to both gl yphosate and IFT. Accordingl y, FG72 so ybean may be integrated into current soy bean pest management practices using gl yphosate, the reby mitigating any

impact on gl yphosate - use trends. Additionally , while not previously used in soy

bean production, IFT represents another herbicide available to U.S. soy bean growers. Despite a trend of gl yphosate substitution in U.S. soy bean production (NRC, 2010 ) , diversity of used her

bicides has increased since 1995 (USDA NASS, 1996 , 2002 , 2007 ) . The potential use of IFT on FG72 so ybean does not represent a shift from this herbicide diversity trend. The use of IFT in U.S. soy bean production may

increase under the Pref

erred Alternative. This is an expected outcome, as IFT was not previousl y utilized in U.S. soy bean production ( EPA, 2011d) . The extent of IFT use in U.S. soy bean production, however, may not substantially increase total pesticide application (lbs. a.i./acre) for several reasons. First, IFT is classified as a restricted use pesticide ( EPA, 2011b ) . IFT may only be applied by

a certified applicator or under the direct supervision of a certified applicator in specific agroenvironments and a certain number of states, thus potentially precluding its common and widespread use ( EPA, 2012b ) . Second, as a pre - emergent/earl y post - emergent herbicide, IFT application is restricted to a short application timeframe in the beginning of a so ybean growing season. This limited application window, coup led with restrictions on annual use (no more than one application per growing season, Appendix A ) and reduced application rates relative to other common soy bean herbicides ( Table 4), suggests that IFT may not substantially increase total pesticide use beyo nd the current projections stated in the No Action Alternative. Lastl y, current use of IFT in field corn suggests that use in soy bean may not be substantial. IFT has not been widel y used in field corn since commercial introduction in 1999 ( Table 5). In 2010, IFT use in field corn totaled 399,000 lbs.; this value was much less than total gl yphosate use (57,536,000 lbs.) and represented onl y 0.11 percent of total herbicide use in corn that same ye ar (USDA -NASS, 2011a) . Contributing to this relatively low application in corn is the application rate of IFT; in contrast to other corn herbicides, such as atrazine (0.9

– 1.8 kg/ha) and metochlor (0.7

– 1.4 kg/ha), IFT is typically applied at the rate of 0.05

– 0.11 kg/ha ( Ramanarayanan et al., 2005 ) . As described in the No Action Alternative, total herbicide use may increase in U.S. soy

bean production due to farm - level response to gl yphosate - resistant weeds (NRC, 2010 ) . A determination of nonregulated status of FG72 so yb ean would likel y contribute to this trend, as it would facilitate the use of an herbicide not previously used in U.S. soy

bean production. H owever, the contribution of IFT to so ybean total herbicide use (lbs. a.i./acre) is likely to be small, due to its use restrictions and reduced application rates (single and annual rate) relative to other common soy

bean herbicides.31

**Table 4**  **.** M ax imum soy

bean herbicide application rates (single and annual application). **Herbicide Active Ingredient Rate/Application (lbs./acre)**  **Rate/Crop Year (lbs./acre)** 2,4 - D, 2 - EHE 0.493 0.503 2,4 - D, BEE 0.426 0.459 2,4 - D, dimeth. salt 0.462 0.475 Ac ifluorfen, sodium 0.287 0.296 Alachlor 1.931 1.931 Bentazon 0.687 0.687 Carfentrazone - ethyl 0.038 0.046 Chlorimuron - ethyl 0.017 0.017 Clethodim 0.096 0.102 Cloransulam - methyl 0.019 0.019 Dicamba, digly salt 0.25 0.25 Fenoxaprop 0.031 0.031 Fluazif op - P - butyl 0.099 0.099 Flufenacet 0.265 0.265 Flumetsulam 0.048 0.048 Flumiclorac - pentyl 0.02 0.028 Flumioxazin 0.066 0.066 Fomesafen 0.19 0.233 Glyphosate 0.63 1.044 Glyphosate amm. salt 0.489 0.745 Glyphosate iso. salt 0.802 1.33 Imazamox 0.03 0 .03 Imazaquin 0.061 0.062 Imazethapyr 0.053 0.053 Imazethapyr, ammon 0.048 0.048 Isoxaflutole (IFT) 0.07 0.07 Lactofen 0.11 0.11 Metribuzin 0.255 0.26 Paraquat 0.492 0.511 Pendimethalin 0.92 0.926 Quizalofop - P - ethyl 0.038 0.041 S - Metolachlor 1.02 3 1.023 Sethoxydim 0.153 0.153 Sulfentrazone 0.087 0.091 Sulfosate 0.967 1.701 Thifensulfuron 0.004 0.004 Tribenuron - methyl 0.008 0.008 Trifluralin 0.818 0.818 Source : USDA -NASS ( 2002 , 2007 ) .32

**Table 5**  **.** Use of gl yphosate and isoxaflutole (IFT) in U.S. corn production, 2000

– 2010. Year Glyphosate application in corn

- Measured in total lb s. Average

glyphosate application in corn

- Measured in total lbs./acre Isoxaflutole

application in corn

- Measured in total lbs. Average

isoxaflutole application in corn

- Measured in total lbs./acre 2010 57,536,000 0.82 399,000 0.07 2005 22,967,000 0 .73 233,000 0.05 2003 11,913,000 0.69 321,000 0.06 2002 3,307,000 0.64 331,000 0.07 2001 6,868,000 0.66 439,000 0.07 2000 4,438,000 0.59 171,000 0.07 Source: USDA -NASS ( 2011a) . 4.2.3 Organic So ybean Production No Action Alternative: Organic So ybean Production Current availability , market demand, and acreage of organic soy bean are anticipated to rem ain unchanged under the No Action Alternative. Similar to market trends for other U.S. organic products, demand of organic soy bean is likely

to increase (USDA - ERS, 2007 ) . Despite this increasing demand, however, the share of U.S. organic soy bean production remains relativel y small and steady . While this flat production of U.S. organic soy bean correlates with an increas e in GE soy bean adoption, there is little or no evidence to suggest a cause - and - effect relationship . An alternative explanation is that U.S. organic so ybean acreage remains limited because of unrelated reasons, such as: 1) the three - ye ar period transition period between conventional and organic farming; 2) a lack of contractors for organic agronomic practices, including pest and nutrient management; 3) intensive labor requirements; 4) fear of criticism from neighbors; 5) An absence of government infrastruc ture and policy support; and 6) unknown risks ( Clarkson, 2007 ; USDA - ERS, 2007 ) . From 2005 - 2008, total organic so ybean acreage ranged between 122,000 and 126,000 acres (USDA - ERS, 2010c ) . This represented less than 0.2 percent of the total U.S. soy bean acreag e for this period and is not anticipated to substantially change in spite of rising domestic demand, due in p art to increasing competition and imports from international organic soy bean producers (USDA - ERS, 2007 ) . Therefore, d omestic demand for organic soy bean and organic soy

bean products appear to be sustained by increasing imports from international organic soy bean producers ( The Organic & Non - GMO Report, 2007 ; USDA - ERS, 2007 ) . Preferred Alternative: Organic Soy bean Production It is not likely

that organic farmers will be substantially affected by a determination of nonregulated status of FG72 soy bean. Soy

bean is primarily

a self - pollinated plant ( OECD, 2010 ) , and there is n o reason to suspect that the biology of FG72 so ybean will increase its potential to outcross with soy bean varieties utilized in organic soy bean production (USDA -33

APHI S, 2012b ) . Field study of FG72 so ybean reproductive biology revealed no substantial differences in factors influencing reproductive potential, including pollen viability , date of emergence, date of 50 percent flowering, and date of maturity ( Bayer, 2011c ) . It is important to note that the current NOP regulations do not specify an acceptab le threshold level for the adventitious presence of GE materials in an product labeled organic (USDA - ERS, 2010c ) . The unintentional presence of the products of excluded methods will not affect the status of an organic product or operation when the operation has not used excluded methods and has taken reasonable steps to avoid contact with the products of excluded methods ( Ronald and Fouche, 2006 ; USDA - AMS, 2010b ) . However, certain markets or contracts may have defined thresholds (Non - GMO - Project, 2010 ) . A determination of nonregulated status of FG72 soy bean is unlikely

to substantially

affect U.S. organic so ybean market conditions. In contrast to other U.S. organic crops, U.S. organic soy bean production has not kept pace with demand (USDA - ERS, 2010c ) . Domestic production of organic so yb ean has not kept pace with demand due to the re asons outlined in the previous No Action Alternative section . The increased demand for organic so yb ean in the U.S. has generally been met b y increasing imports from international organic so ybean producers ( The Organic & Non - GMO Report, 2007 ; USDA - ERS, 2007 ) . **4.3 Physical Environment**  4.3.1 Soil Quality No Action Alternative: Soil Quality Soil quality in the agroenvironment is influenced by a variety of agronomic practices, including the crop cultivated and its associated management practices. Inparticular, tillage is strongly correlated with soil quality (NRC, 2010 ) . As discussed in Section 4 .2.2 , conservation tillage in U.S. soy bean is generally associated with 30 percent or greater remaining plant residue and reduced soil erosion and compaction. The use of conservation tillage in U.S. soy bean production has increased and is not expected to change under the No Action Alternative, an effect attributed to the gl yphosate - tolerant soy bean s ys tem. Consequently , because of the strong relationship between conservation tillage and soil quality ( Holland, 2004 ) , soil quality in soy bean fields is not anticipated to substanti ally change under the No Action Alternative. Soil quality

may also be affected by

the addition of pesticides. Under the No Action Alternative, insecticide use will remain as it is currentl y practiced and limited to a small percentage of total U.S. soy bean acreage (USDA -NASS, 2007 ) . A dditionally , gl yphosate is anticipated to remain the most widely - applied herbicide in U.S. soy bean production, continuing the current trend. Preferred Alternative: Soil Quality Soil quality

in U.S. soy

bean production fields is unlikely to be substantially affected under the Preferred Alternative. The increasing adoption of conservation tillage has been partiall y enabled by the capacity

to apply a broad - spectrum herbicide [gly phosate] over a tolerant variety [gly phosate - tolerant soy

bean]. FG72 soy

bean is t olerant to gl yphosate and IFT, both broad -34

spectrum herbicides. Thus, conservation tillage trends, and its direct effects on soil quality , are unlikely to deviate as currently

practiced. A consequence of conservation tillage is the incorporation of plant material from the preceding crop into the soil ( CTI C, 2008 ) . Consequently , any changes in remaining plant tissue from previous growth may

affect soil quality . However, FG72 so y bean plant material is unlikely to substantially

affect soil quality , as compositional analy sis of FG72 soy bean tissue demonstrates that it is not substantially different from its non - GE parent variety, Jack ( Bayer, 2011c ; USDA APHI S, 2012b ) . Under the Preferred Alternative, gly phosate and IFT may

be applied to the soil during FG72 cultivation . Gly

phosate use has been reviewed in previous APHI S documents and is not anticipated to negativel y affect soil quality , when it is used in accordance with the EPA restricted use label (USDA - APHIS, 2012a) . IFT, at present, has been primarily applied on field corn. As described in Appendix A , IFT yi elds a DKN and benzoic acid derivative through biotic or abiotic processes. IFT itself is n ot likely to substantially

affect soil quality , as degradation of IFT is generall y rapid, resulting in a half - life of only

0.5

– 13.9 day s across a variety of soil t ypes ( Beltrán et al., 2002 ; EPA, 2011b ; Papiernik et al., 2007 ) . Furthermore, the estimated half - life of DKN is 61 day s, facilitated by aerobi c soil metabolism ( EPA, 1998 ) . DKN is the bioactive principle of IFT, and thus, may be responsible for non - target plant injury that may result from growth on the treated soil. However, EPA label use restrictions on IFT formulations places minimum limits on when another crop may be planted following IFT application. These intervals, ranging from 4 - 18 months, exceed the half - life of DKN and are designed to mitigate any incidental plant injury

from the soil ( Baye r, 2011b ) . As a consequence of its registration of IFT, EPA has effectivel y determined that there is no unreasonable environmental risk if the end user adheres to the label use restrictions when applying IFT herbicide formulations. 4.3.2 Water Resources No Action Alternative: Water Resources Under the No Action Alternative, water resou rces associated with soybean production is not likely to be substantially affected . H erbicide - tolerant soy beans , cultivated on 93 percent of soy bean acreage , have resulted in the adoption of increased conservation practices (NRC, 2010 ; USDA - ERS, 2011a) . These conservation practices, including reduced tillage and precision agriculture , play

a major role in water conservation and maintaining water quality by minimizing soil erosion (USDA -NRCS, 2006 ) . As discussed previously , conservation tillage trends are not expected to change in U.S. soy bean production from what is currentl y practiced; accordingl y, the impacts of conservation tillage on water resources are also expected to not change. Preferred Alternative: Water Resources Cultivation of FG72 soybean is likely to permit the continued use of conservation tillage as it is c urrentl y practiced, and its effects on water resources through the mitigation of water l oss and runoff attributes, is not expected to be substantially different from the No Action Alternative . T he agronomic performance of FG72 so ybean is similar to that of its non - transgenic parent variety, Jack. This implies that FG72 so ybean does not requ ire more moisture. Therefore, its35

irrigation requirements will not differ substantially from that of so ybean varieties that are commerciall y available ( Baye r, 2011c ; USDA - APHI S, 2012b ) . Under the Preferred Alternative, g ly phosate and IFT may

be applied on FG72 soy

bean . Gly phosate is applied to most U.S. soy bean acre age ( Dill, 2005 ) ; it will likely be applied to FG72 so ybean following a determination of nonregulated status. Gl yphosate use has been reviewed in previous APHI S documents and is not anticipated to ne gatively affect water resources when it is used in accordance with the EPA restricted use label ( USDA - APHIS, 2012a) . With regard to IFT application, degradation occurs rapidly in both soil and aqueous environments ( Beltrán et al., 2002 ; Rice et al., 2004 ; Taylor - Lovell et al., 2002 ) . Thus, IFT is not expected to persist in groundwater (aquifers) or surface water ( DATCP, 2002 ; EPA, 2001a) , with detection only

occurring shortl y after field ap plication ( Scrib ner et al., 2006 ) . DKN, the bioactive principle of IFT, is relativel y s table and more mobile in the aqueous phase than parent IFT ( EPA, 2011d) . Laboratory and tile - drain studies demonstrated the relative stability of DKN in aqueous environments and suggested that it may persist in surface water ( DATCP, 2002 ; EPA, 2011d) . Detection of DKN in surface water resources surrounding midwestern corn fields further demonstrated the persistence and mobility of DKN under field conditions ( EPA, 2001a , 2002 ; Rector et al., 2003 ; Scribner et al., 2006 ) . Presence of a metabolite in a water resource does not, in itself, represent a negative impact. More relevant is the plausibility and magnitude of an impact. Phy totoxicity risks to non - target terre strial plants due to the presence of DKN in field runoff and surrounding surface water precipitated the characterization of IFT as a restricted use pesticide b y the EPA ( EPA, 2011b ) . Risk to aquatic plants, birds, mammals, invertebrates, and fish from IFT and DKN were determined to be below the EPA level of concern, suggesting that the toxicity of IFT and DKN is relativel y low ( EPA, 2011b ) (Appendix A). Relativ e to other herbicides applied to U.S. soy bean fields, IFT and its degradates fall within the range of environmental impact quotient (EIQ) for several parameters related to water resources, such as leaching potential, and effects on fish, birds, beneficial organisms, and ecology ( Table 6). Indeed, when compared to other herbicides applied on soy

bean, IFT appears to possess an average leaching potential ( Table 6). As a consequence of its registration of IFT, EPA has effectivel y determined that there is no unreasonable environmental risk if the end user adheres to the label use restrictions when applying IFT herbicide formulations. EPA label directions include application restrictions plus requirement for a certified applicator to minimize effects on nearb y environments. IFT is currentl y undergoing a registration review b y EPA ( EPA, 2011 b ) . If EPA determines that additional restrictions beyond current restrictions (Appendix A) on IFT use are required to mitigate environmental risk to non - target plant communities, then it is expected that EPA w ould amend IFT use labels accordingl y.36

**Ta ble**  **6 .**  Environmental Impact Quotient (EIQ) of soy bean herbicides with respect to several factors related to water resources . High lighted rows indicate an herbicide that was applied on a percentage of so yb ean acres greater than 5 p ercent in 2006. I soxaflutole is generall y not applied on soy bean. **Active ingredient EIQ** 

**Review date**  **Leaching Fish**  **Birds Beneficials**  **Ecology** 2,4 - D, 2 - EHE April - 04 1 5 6 15 35 2,4 - D, dimethyl salt April - 04 5.00 1.00 6.00 15.00 31.00 Chlorimuron - ethyl Ap ril - 04 5.00 3.00 6.00 24.60 42.60 Clethodim Dec - 00 5.00 1.00 6.00 15.00 31.00 Cloransulam - methyl Jan - 03 3.00 3.00 6.00 15.00 33.00 Fluazifop - P - butyl Mar - 09 1.00 15.00 4.65 21.00 72.15 Flumiclorac - pentyl Mar - 09 5.00 3.00 9.00 25.20 46.20 Flumioxazin De c - 05 2.10 10.20 6.00 24.60 49.80 Fomesafen Mar - 09 5.00 1.00 7.65 17.64 32.59 Glyphosate amm. Salt April - 08 1 5 6 15 35

Imazaquin Mar - 09 5.00 1.00 3.00 25.00 32.00 Imazethapyr Mar - 09 5.00 1.00 7.65 17.54 32.49 Metribuzin Apr - 03 5.00 1.00 27.00 32.10 69 .10 Paraquat Mar - 09 1.00 5.00 10.65 13.97 35.92 Pendimethalin Mar - 08 1.00 25.00 9.00 30.00 73.00 S - Metoachlor Jan - 03 3.00 9.00 12.00 15.00 45.00 Sulfentrazone Jan - 04 5.00 1.00 9.00 8.20 21.20 Sulfosate Mar - 01 3.00 3.00 9.00 45.00 66.00 Tribenuron - met hyl Apr - 04 3.10 3.40 6.00 15.00 33.40 Trifluralin Apr - 08 1.00 25.00 9.00 5.00 42.00 Isoxaflutole Jan - 04 3.00 9.00 6.00 15.00 39.00 Source s : NY State IPM Program ( 2 012b ) and USDA -NASS ( 2007 ) . 4.3.3 Air Quality No Action Alternative: Air Quality All agricultural practices have the potential to cause negative impacts to air quality. Agricultural emission sources include smoke from machinery , pesticide drift from spraying, GHG emissions, and particulate matter ( EPA, 2010d ; USDA -NRCS, 2006 ) . Under the No Action Alternative, c urrent impacts to air quality associated with soybean acreage and cultivation practic es would not be affected. Agronomic practices associated with conventional soybean production that contribute to air quality and GHG emissions, including tillage, cultivation,37

irrigation, pesticide application, fertilizer applications and use of agriculture equipment, would not be expected to change. Preferred Alternative: Air Quality As previously

discussed in Section 4.2, the majority of agronomic practices (with the exception of IFT use) commonl y utilized in conventional soybean production are not likel y to be substantially

different between FG72 and conventional soy bean. Accordingly , a determination of a nonregulated status of FG72 so ybean is unlikely to change the use of agricultural practices with the potential to affect air quality from what is curr entl y practiced. In particular, the adoption of conservation tillage is generall y increasing in conventional so ybean production, partially enabled by

the use of effective, non - selective herbicides such as gly phosate. Under the Preferred Alternative, FG72 soy bean would also permit the use of two non - selective herbicides (gl yphosate and IFT) that may facilitate conservation tillage. Thus, the effects of tillage on air quality conservation tillage trends would be maintained and not deviate substantially as it is currentl y practiced in typ ical soy bean production practices. 4.3.4 Climate Change No Action Alternative: Climate Change Under the No Action Alternative, c urrent impacts on climate change associated with soybean production would not be affected. Agronomic practices associated with soy bean production such as tillage, cultivation, irrigation, pesticide application, fertilizer applications and use of agriculture equipment would continue on soy beans grown throughout the region. FG72 so ybean use would be limited to areas APHIS has approved it for regulated releases under the No Action Alternative . Agronomic management practices and phenotypic characteristics regarding FG72 so ybean are similar to those of conventional soy bean, so impact from soy bean varieties wo u ld be minimal. M easurable effects from these confined field releases would also be minor because of the small scale of management and acreage relative to current soy bean production in the U.S. Preferred Alternative: Climate Change As described in Section 4.2.1 , the range and area of U.S. soy bean production is not likely to expand under the Preferred Alternative. As described in the Bayer petition ( Baye r, 2011c ) and USDA - APHIS PPRA (USDA - APHI S, 2012b ) , FG72 soy bean requires management strategies similar t o that for conventional soy bean production, thus precluding changes in agricultural activities that may

affect climate change, such as machine usage and tillage. Collectively , because the range, area, and agronomic practices of soy bean are unlikel y to change following a determination of nonregulated status of FG72 so yb ean, the agricultural impacts of soy bean cultivation are also unlikely to change under the Preferred Alternative. While agricultural activities may affect climate change, the converse is also true; climate change may affect agriculture. For example, c limate change may result in shifts of herbivorous insects to higher latitudes. There is evidence that insect diversity and vegetative consumption intensity increase with increasing temperature at the same latitude in the fossil record ( Bale et al., 2002 ) .38

How climate change will affect individual species of pest insects will depend on their phy siology , feeding behavior, and overwintering strategies ( Bale et al., 2002 ) . In cases where climate change favors the expansion of the range of soy bean pests, additional soy bean acres may be treated with insecticide s. FG72 so ybean is not any more susceptible to insect herbivory than conventional soy

bean varieties (USDA - APHIS, 2012b ) , so change in insect pressure resulting from climate change is likely to impact FG72 soybean just as it would conventional soy bean. **4.4 Biological Resources**  4.4.1 Animal Communities No Action Alternative : Animal Communities Soy bean production fields may be host to many

animal and insect species. Mammals and birds may use so yb ean fields and the surrounding vegetation for food and habitat throughout the ye ar. Invertebrates can feed on soy bean plants or pr ey

upon other insects living on soy bean plants as well as in the vegetation surrounding so yb ean fields . Under the No Action Alternative, conventional soy bean production would continue while FG72 soy bean remains a regulated article. Potential impacts of GE and non - GE soy bean production practices on non - target animals would be unchanged. Preferred Alternative: Animal Communities As described in Chapter 4.2 , land use and agricultural production of FG72 soy bean under the Preferred Alternative is likely to continue as currently

practiced. Consequently , an y impact to animal communities as a result of soy bean production practices under the Preferred Alternative is likely to be similar to the No Action Alternative. Consumption of FG72 soybean is unlikely to substantially affect non - target organisms, such as animals, birds, or insects . 2mEPSPS has been previously anal yz ed and approved by several international regulatory

agencies, demonstrating that it is not likely to have any

significant impact on animal health ( CFIA, 1998 ; FSANZ, 2001 ; SCF, 2002 ; USDA - APHI S, 1997 ) . Though HPPD W336 has not previously been evaluated, there is no reason to suspect it would present a risk to non - target organisms . HPPD proteins are ubiquitous in the environment and are not novel. B ioinformatic anal ys is of HPPD W336 showed no significant lengthwise alignment with known toxins or allergens ( Baye r, 2011c ) . Additionally , compositional analy sis of FG72 soy bean proximate and fiber components, amino acid and fatty acid content, and antinutrients and isoflavone concentrations revealed no substantial differences between it and conventional soy bean varieties ( Bayer, 2011c ) . Non - target organisms may be exposed to gl yphosate and IFT under the Preferred Alternative. The majority

of U.S. soybean acreage is already subject to gl yphosate application (USDA NASS, 2007 ) ; consequently , exposure to gl yphosate through the cultivation of FG72 so ybean is not likely to increase non - target organism exposure to gl yphos ate. Based on information provided in existing APHI S EAs (USDA - APHI S, 2012a) , exposure to glyphosate by non - target organisms is expected to be similar to the No Acti on Alternative. The potential impact of IFT on non - target organisms has been evaluated b y the EPA ( EPA, 2011b , 2011d) . In summary ,39

following three separate ecological risk assessments, EPA concluded that the level of concern for acute and chronic risks for birds, mammals, and fish was not exceeded as a result of IFT application (T ables A3 - A4, Appendix A). On an acute contact an oral basis, IFT was determined to be practically

non - toxic to honey

bees ( Apis mellifera ) ( Table 7) ( EPA, 2011d) . My sid shrimp ( Mysido psis bahia ), an estuarine invertebrate species, was found to be highly sensitive to IFT (L C 50 = 0.018) ( Table 8) ( DATCP, 2002 ) ; however, given the rapid decay of parent IFT to DKN and the decreased sensitivity of M. bahia to DKN (L C 50 = 3.6) ( EPA, 2 011d) , this may be less of an issue in field conditions. As a result of these conclusions, it is unlikely that IFT would pose a risk to animal communities under the Preferred Alternative. **Table 7**  **.** Summary

of the most sensitive e ndpoints from submitted terrestrial toxicity studies for isoxaflutole (IFT) . **Taxa represented**  **Species**

**(common name) Toxicity value**  **Comments** Birds, terrestrial Bobwhite quail LD 50 > 2150 mg/kg - bw phase ( Colinus

virginianus ) LD 50 > 4255 mg/kg food No observed mortalities at amphibians Mallard duck LD 50 > 2150 mg/kg - bw highest treatment level. and reptiles ( Anas

platyrhynchos ) LD 50 > 4255 mg/kg food LD 50 > 5000 mg/kg - bw Acute inhalation LC50 > 5.23 Terrestrial Laborat ory rat mg/L. mammals ( Rattus

norvegicus ) NOAEC = 17.4 mg

a.i./kg Values based on exposure to food males; LOAEC = 414 mg/kg - food based on decreased body weight in parents and offspring. Terrestrial invertebrates Honey bee

( Apis mellifera ) LD 50 > 5000 mg/kg - bw No observed mortalities at highest treatment level. Oral LD 50 > 168.7 ug/bee. Source: EPA ( 2011d) . **Table 8**  **.** Summary

of the most sensitive endpoints for submitted aquatic toxicity studies for isoxaflutole (IFT) . **Taxa represented**  **Species**

**(common name)**  **Toxicity**

**value (mg a.i./L)**  **Comments**

Freshwater fish and aquatic Rainbow trout

( Oncorhychus 96 - hr LC 50 > 1.7 No observed mortalities at highest treatment level. 1.7 ppm represents maximum water solubility obtainable under test conditions.40

**Taxa represented**  **Species**

**(common name)**  **Toxicity**

**value (mg a.i./L)**  **Comments** phase amphibians mykiss ) NOAEC = 0.096 No toxicity data are available for this taxa. NOAEC derived using ACR for mysid shrimp (17.8) and acute toxicity value for rainbow trout. Freshwater Water flea 48 - hr LC 50 > 1.5 No observed immobility at highest treatment level. 1.5 ppm represents maximum water solubility obtainable under test conditions. invertebrates ( Daphnia magna ) NOAEC = 0.087 No toxicity data are available for this taxa. NOAEC derived using ACR for mysid shrimp (17.8) and acute toxicity value for water flea. Estuarine/ Marine fish Sheepshead

minnow ( Cyprinodon variegates ) 96 - hr LC 50 > 6.4 No obse rved immobility at highest treatment level. 6.4 ppm represents maximum water solubility obtainable under test conditions. NOAEC = 0.36 No toxicity data are available for this taxa.

NOAEC derived using ACR for mysid shrimp (17.8) and acute toxicity va lue for sheepshead minnow. Estuarine/ Mysid shrimp 96 - hr LC 50 > 0.0178 Slope = 2.9. Marine invertebrates ( Mysidopsis

bahia ) NOAEC = 0.001 LOAEC = 0.0019 based on effects to survival. Source: EPA ( 2011d) . 4.4.2 Plant Communities No Action Alternative: Plant Communities One of the highest priorities in soy bean production is weed management ( Hoeft et al., 2000 ) . Weeds compete with so ybean for water, soil nutrients and light, and may ultimately redu ce yi eld. Growers use cultural methods, cultivation and herbicides to control crop competitors, and , depending on the strategies chosen, different herbaceous annuals, perennials, or even woody species can become established ( Hoeft et al., 2000 ) . Weeds present during an entire growing season can result in soy

bean yield losses ranging from 12 to 80 percent ( Barrentine, 1989 ) . Weed species that typically inhabit soybean production systems will continue to be managed through the use of mechanical, cultural, and chemical control methods, including the us e of glyphosate and other registered herbicides. The majority of U.S. soybean acres will continue to be subject to herbicide application. No changes to cultivation practices are expected under the No Action Alternative. Preferred Alternative: Plant Communities41

Under the Preferred Alternative, FG72 soy bean is not expected to affect plant communities due to toxicity

or allergenicity

of the transgene proteins. Both introduced proteins, 2mEPSPS and HPPD W336, are not derived from organisms that are known for pathogenic or toxic effects on plants; these traits themselves are effectivel y benign in the environment ( Bayer, 2011c ) . There are no compatible wild relatives of soy bean in the U.S. ( OECD, 2010 ) , so there will be no impact on the wild genetic resources of so yb ean following a determination a nonregulated status of FG72 so ybean. Furthermore, FG72 so yb ean does not display or possess any

weedy characteristics, and thus, is not expected to behave as a weed (USDA - APHIS, 2012b ) . FG72 so ybean will permit the continued use of gl yphosate on soybean, as described in Section 4.2.2 . Thus, any

impact of gl yphosate use on the plant community will be the same as the No A ction Alternative. Based on information provided in existing APHI S EAs (USDA - APHIS, 2012a) , the impacts on the plant community in soybean from gl yphosate is expected to be similar to the No Action Alternative. As described in Section 4.2.2 , FG72 so ybean may also facilitate the increased use of IFT in U.S. soy bean production. IFT, through its degradation to DKN, functions as a nonselective herbicide. Therefore, both non - target plant and weed species may experience high levels of toxicity following exposure to IFT. Possible routes of exposure include direct exposure in the agricultural field and runoff. Soy bean weed species are the most likely to be exposed to IFT through direct application. As a nonselective herbicide, IFT can be expected to control a wide variety so ybean weed species ( Table 9). Direct exposure of weeds to IFT under the Preferred Alternative is not anticipated to be substantially different than dir ect exposure of weeds to alternative herbicides under the No Action Alternative, as IFT represents yet another herbicide in a growing diversity of herbicides utilized in soy bean production ( Section 4.2.2 ). **Table 9**  **.** Control of commo n broadleaf and grassy weeds b y isoxaflutole (IFT) (Balance® Pro). C = controlled; S = suppression; and N = not controlled or suppressed. **Broadleaf Weeds Grassy Weeds**  Palmer amaranth - C Hairy nightshade - C Barnyardgrass - C Buff alobur - C Field pennycress - C Large crabgrass - C Burcucumber - S Broadleaf plantain - C Smooth crabgras - C Carpetweed - N Prostrate pigweed - C Wooly cupgrass - C Chamomile spp. - C Redroot pigweed - C Bristly foxtail - C Common chickweed - C Smooth pigweed - C Giant foxtail - C Cocklebur - N Common purslane - C Green foxtail - C Dandelion - C Wild radish - C Robust purple foxtail - C Galinsoga - C Common ragweed - C Robust white foxtail - C Henbit - S Giant ragweed - S Yellow foxtail - C Jimsonweed - C Russian thistle - C Goosegrass - C Kochia - C Shepherds purse - C Johnsongrass, seedling - C Lambsquater - C Pennsylvania smartweed - C Fall panicum - C42

**Broadleaf Weeds Grassy Weeds**  Venice mallow - C Toothed spurge - C Texas panicum - C Marestail - C Wild sunflower - N Wild proso millet - C Annual morning glory - C Velvetleaf - C Field sandbur - S Wild mustard - C Common waterhemp - C Shattercane - S Black nightshade - C Tall waterhemp - C Broadleaf signalgrass - C Eastern black nights hade - C Witchgrass - N Adapted from DATCP ( 2002 ) . As described in Section 4.3.2 , runoff may pose an environmental risk to non - target plants ( EPA, 2011d) . However, as a consequence of its registration, EPA has determined that there is no unreasonable environmental risk if the end user adheres to the label use restrictions when applying IFT herbicide formulations. EPA label directions include application restrictions plus requirement for a certified applicator to minimize effects on nearb y environments ( Baye r, 2011a , 2011b ) . Violators of the regulations are liable for all negative consequences of their actions. This serves as an added incentive to farmers who use restricted use pesticides, so they are more likely to carefull y follow its label restrictions. Given that the leaching potential of IFT is not substantially

higher than m any

currently- registered soy

bean herbicides ( Table 6), it is unlikely that IFT poses an y more of a risk to non - target plants than the herbicides that would otherwise be utilized under the No Action Alternative. IFT is currentl y undergoing a registration review b y EPA ( EPA, 2011b ) . If EPA determines that additional restrictions beyon d current restrictions (Appendix A) on IFT use are required to mitigate environmental risk to non - target plant communities, then it is expected that EPA w ould amend IFT use labels accordingl y. Weed populations can change in response to multiple agricultural management decisions, including those related to herbicide application. At present, nine gl yphosate - resistant weeds have been identified in soy bean fields (Figure 5 ) , inhabiting approximately two million acres of farmland in the U.S. ( Hubbard, 2008 ) . As described in Section 4.2.2 , FG72 soy bean may facilitate the use of IFT in U.S. soy bean production. Following a determination of nonregulated status of FG72 so ybean, IFT application may be utilized to control gly phosate - resistant weeds in U.S. soy bean fields. Possessing an alternative MoA, IFT is expected to control gl yphosate resistant weeds. Of the nine gl yphosate - resistant weeds found in U.S. soybean fields, horseweed, Palmer amaranth, common waterhemp, common ragweed, johnsongrass, goosegrass, and kochia are controlled b y IFT ( Table 10). Control of the remaining gl yphosate - resistant weeds potentially

found in soy

bean fields, such as giant ragweed or Italian ryegrass, may be controlled by alternative herbicide use alone or in conjunction with IFT. **Table 10**  **.** Control of glyphosate - resistant broadleaf and grass y weeds found in soy bean by isoxaflutole (IFT) (Balance ® Pro). C = controlled; S = suppression; and N/T = not determined. **Broadleaf Weeds Grassy Weeds**  Horseweed (Marestail) ( Conyza candensis ) - C Goosegrass ( Eleusine indica ) - C43

**Broadleaf Weeds Grassy Weeds**  Kochia ( Kochia scoparia ) - C Italian Ryegrass ( Lolium spp. multiflorum ) - N/A Palmer Amaranth ( Amaranthus palmeri ) - C Johnsongrass ( Sorghum halepense ) - C Ragweed, Common (Ambrosia artemisiifolia ) - C Ragweed, Giant ( Ambrosia trifida ) - S Waterhemp, Common ( Ama ranthus tuberculatus ) - C Adapted from DATCP ( 2002 ) . Since 2009, four populations of common waterhemp in I llinois, I owa, and Nebraska corn fields were reported to be resistant to 4 - HPPD inhibitors ( Heap, 2011b ) . While three of these bioty pes were resistant to the triketone family of 4 - HPPD inhibitors, cross - family resistance to IFT may be possible. One example of this was found in 2011 in a common waterhemp bioty pe from Iowa that displayed cross - family resistance to triketone - based 4 - HPPD inhibitors as well as IFT ( Heap, 2011b ) . The conditions leading to the advent of at least one of these reported cases is not likely to be common in FG72 soy bean fields. In the I llinois bi oty pe found in 2009, an absence of crop and herbicide rotation in the corn seed production field contributed to the development of 4 - HPPD resistance ( Hausman et al., 2011 ) . Unlike seed corn production fi elds, however, the majority of so ybean production fields are rotated with another crop (USDA - ERS, 2011b ) . FG72 soy bean fields are not anticipated to be any different. Under the Pr eferred Alternative, FG72 soy bean will permit the pre - emergent use of both gl yphosate and IFT; pre - emergent use of an herbicide was sufficient to control this population of 4 - HPPD resistant waterhemp ( Sy ngenta, 2010 ) . 4.4.3 Gene Flow and Weediness No Action Alternative: Gene Flow and Weediness Soy bean is a self

- pollinated species, propagated by seed ( OECD, 2010 ) . Pollination ty pically takes place on the day

the flower opens. The soy bean stigma is receptive to pollen approximately 24 hours before anthesis and remains receptive for 48 hours after anthesis. Anthesis normally occurs in late morning, depending on the environmental conditions. The pollen usually remains viable for two to four hours, and no viable pollen can be detected b y late afternoon. Natural or artificial cross - pollination can onl y take place during the short time when the pollen is viable. As a result, so ybean is considered to be a highl y s elf - pollinated species, with cross - pollination to adjacent plants of other soy bean varieties occurring at a very low frequency (0 to 6.3 percent) ( Caviness ; Ray

et al., 2003 ; USDA - APHI S, 2011 ; Yoshimura et al., 2006 ) . Under the No Action Alternative, conventional soy bean varieties, including GE soy bean varieties no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act, will co ntinue to be grown commercially while FG7244

soy bean will remain a regulated article. Soybean cultivation practices are expected to remain the same. Gene flow from current commerciall y available GE cultivars to non - GE so ybean cultivars is expected t o remain unchanged from the current conditions. Preferred Alternative: Gene Flow and Weediness There are no compatible relatives of so ybean in the U.S. Thus, gene flow is only possible between domesticated soy bean plants ( OECD, 2010 ) . Soy bean is predominantly

a selfpollinated species ( OECD, 2000 ) , yet a small amount of outcrossing does occur. However, c urrent cultivation practices to prevent out - crossing have been deemed sufficient to prevent unwanted gene flow. For soy bean, the Association of Official Seed Certifying Agencies (AOSCA) mandates a zero isolation distance: “ Fields of soy beans shall be separated from an y other variety or uncertified seed of the same variety by a distance adequate to prevent mechanical mixture . ” FG72 so ybean, compared to its non - transgenic parent variety (Jack), did not exhibit any changes in reproductive characteristics that would increase likelihood of gene flow, such as fecundity, seed dispersal, increased persistence, or pollen viability /g e rmination ( Bayer, 2011c ; USDA APHI S, 2012b ) . Thus, under the P referred Alternative, the likelihood of gene flow from FG72 soy bean to other soy

bean varieties is not substantially different than between current soy bean varieties. FG72 so ybean is not likely to be weedy. So ybean is not identified as a weed in the U.S. Phenoty pic and agronomic characteristics of FG72 soy bean were evaluated in a comparative manner to assess plant pest potential ( OECD, 1993 ) . These assessments included 17 plant growth and development characteristics: earl y stand count, plant vigor, day s to flowering, flower color, leaf shape, health rating at stage V4 - 5, health rating at stage R1, health rating of mature plants, pubescence color, pod color, hilum color, canopy , day s to maturity , yield in bu/ac, lodging, final stand count and po d shatter ( Baye r, 2011c ) . Results of these evaluations indicate that there is no fundamental difference between FG72 soy bean and conventional soy bean for traits associated with weediness. Collectively , these findings support the conclusion that FG72 soy bean is no more likely

to be a weed compared to conventional soy bean (USDA - APHI S, 2012b ) . 4.4.4 Microorganisms No Action Alternative: Microorganisms In particular, the soil microbial community is an integral ecos ys tem component that may provide and sustain critical ecological processes. Nutrient cycling, establishing soil structure contributing to plant growth, metabolism of deleterious components are all dependent on the microbial constituents. The health and growth of these microbes may be influenced b y man y processes and conditions in agriculture, such as the crop cultivated or the tillage method utilized ( Steenwerth et al., 2002 ) . Under the No Action Alternative, so ybean cultivation practices would continue as currently practiced. Microbes in the field would continue to be exposed to common agronomic practices, gl yphosate, and other pesticides applied to soybean.45

Preferred Alternative: Microorganisms Field observations were conducted to ass ess potential agronomic differences between FG72 soy bean and conventional soy bean in 2003 and 2008 and at a total of 15 planting sites ( Bayer, 2011c ) . The disease analy sis included observation of a wide range of bacterial and fungal pathogens, including downy mildew ( Peronospora manshurica ); bacterial blight ( Pseudomonas syringae pv . Glycinea ); Cercospora leaf blight ( Cercospora kikuchii ); brown spot (Septoria glycines ); frogeye leafspot ( Cercospora sojina ); powdery mildew ( Microsphaera diffusa ); and sudden death s yndrome (Fusarium virguliforme ). No differences in disease susceptibility were observed between FG72 and conventional so ybean, suggesting that the two introduced traits did not alter soy

bean interactions with mic roorganisms in the field (USDA - APHI S, 2012b ) . The soil microbial community is affected b y standard agronomic practices, such as tillage patterns, agricultural inputs, and rotations strategies of the crop cultivated ( Steenwerth et al., 2002 ) . FG72 so ybean requires similar cultivation practices as commercialized soy bean varieties, suggesting that a determination of nonregulated status is unlikely t o substantially

change current soy bean production practices. In particular, tillage patterns have been identified as an important determinant of soil microbial community and structure ( Eileen J, 2001 ; Lu pwayi et al., 1998 ) . Consequently , under the Preferred Alternative, FG72 soy bean is unlikely

to substantially

affect microbial community

and structure be cause it represents another herbicide - tolerant so ybean variety that may enable conservation tillage strategies widel y practiced in U.S. soy bean production (NRC, 2010 ) . Further support is evident from the decomposition of FG72 soy bean plant material in the field following the implementati on of conservation tillage ( CTIC, 2008 ) . It is unlikely

to substantially

affect the soil microbial community because FG72 soy

bean does not substantially

differ from conventional soy bean in compositional factors, including proximate and fiber components, amino and fatty acids, and relevant soybean anti - nutrients and isoflavones (USDA - APHIS, 2012b ) . 4.4.5 Biodiversity No Action Alternative: Biodiversity Biological diversity, or the variation in species or life forms in a n area, is highl y managed in agricultural s ys tems. Farmers ty pically plant crops that are geneticall y adapted to grow well in a specific area of cultivation and have been bred for a specific market. In conventional agriculture, farmers want to encourage h igh yi elds from their corn crop, and will intensively manage plant and animal communities through chemical and cultural controls to protect the crop from damage. Therefore, the biological diversity in agricultural sy stems (the agro - ecos ys tem) is highl y man aged and may

be lower than in the surrounding habitats. Under the No Action Alternative, FG72 so ybean would continue to be a regulated article . Growers and other parties who are involved in production, handling, processing, or consumption of soy bean wou ld continue to have access to conventional soy bean varieties , including GE soy bean varieties that are no longer subject to the regulatory requirements of 7 CFR part 340 or46

the plant pest provisions of the Plant Protection Act . Agronomic practices associat ed with conventional soy

bean production such as tillage, cultivation, irrigation, pesticide application, fertilizer applications and agric ulture equipment would continue unchanged. Animal and plant species that typicall y inhabit soybean production fields will continue to be affected b y currentl y utilized management plans and sy stems, which include the use of mechanical, cultural, and chemical control methods. Preferred Alternative: Biodiversity Although so ybean production fields are cultivated as plant mon ocultures to optimize yield, the adjacent landscape may

harbor a wide variety

of plants and animals . Broad spectrum herbicide application has the potential to impa ct off - site plant communities. Under the Preferred Alternative, cultivation, management, an d land - use decisions related to FG72 soy bean is not likely to be substantially

different from conventional soy bean varieties. Therefore, the four primary determinants of biodiversity in an agroecosy stem (1: D iversity of vegetation within and around the agroecos ys tem; 2: P ermanence of various crops within the sy stem; 3: Intensity of management, including selection and use of insectic ides and herbicides; and 4: E xtent of isolation of the agroecosystem from natural vegetation) ( Altieri, 1999 ) ar e likely to remain unchanged under the Preferred Alternative. **4.5 Human Health**  No Action Alternative: Human Health Under the No Action Alternative, human exposure to existing traditional and GE soy bean varieties and their products would not change. Furthermor e, so ybean growers and farm workers will continue to be exposed to existing traditional and GE so ybean varieties and their respective cultivation practices. In particular, so ybean growers and farmworkers may be exposed to a variety of EPA - registered pesti cides related to soybean pest management in both GE and non - GE soy bean production s ys tems. Worker safety is taken into consideration when a U.S. EPA pesticide label is developed during the registration process. When use is consistent with the label, pesticides present minimal risk to the worker. No changes to current worker safety are anticipated under the No Action Alternative. Preferred Alternative: Human Health Baye r CropScience initiated the consultation process with FDA for the commercial distributi on of FG72 so ybean and submitted a safety and nutritional assessment of food and feed derived from FG72 so yb ean to the FDA on December 3 , 2009 . FDA is currentl y evaluating the submission, and as of March 16 , 201 2 , has not completed the consultation. Public health concerns surrounding GE so ybean primarily involve the human consumption of GE soy bean products. FG72 soy bean contains two introduced proteins, 2mEPSPS and HPPD W336. 2mEPSPS has been previously anal yz ed and approved by several international r egulatory agencies, thus demonstrating that it is not likely to have any

significant impact on human health ( CFIA, 1998 ; FSANZ, 2001 ; SCF, 2002 ; USDA - APHI S, 1997 ) . HPPD W336 is currentl y being anal yz ed b y s everal regulatory agencies ( CFIA, 2011 ; EFSA, 2011a ; FSANZ, 2011b ) . However, there is no evidence to suggest th at HPPD W336 would be detrimental to general human health.47

Bioinformatic anal ys is of HPPD W336 showed no significant lengthwise alignment with known toxins or allergens ( Baye r, 2011c ) . HPPD W336 is derived from P. fluorescens , a ubiquitous, soil - borne bacterium with a history of safe use ( Maurhofer et al., 1994 ; Sanger, 2012 ) . While P. fluorescens may

occur as an opportunistic pathogen in humans, this is generally limited to immune - compromised patients ( McKellar, 1982 ; Wong et al., 2011 ) . A comparison of FG72 soy bean with conventional soy bean varieties reveals compositional equivalence. Anal ys is of FG72 soy b ean proximate and fiber components (moisture, protein, fat, ash, carboh ydrates, ADF, and NDF), amino acids, fatty acid content (C16:0; C18:0; C20:0; C22:0; C24:0; C18:1; C20:1; C18:2; and C18:3), antinutrients (phy tic acid, raffinose, stach yose, letchtin, and try

psin inhibitor), and isoflavones (daidzin, genistin, gl ycitin, daidzein, genistein, and gl ycitein) demonstrated that FG72 so yb ean is not compositionally different from currentl y available so ybean varieties ( Bayer, 2011c ; USDA - APHI S, 2012b ) . The characterization of soy bean seed allergens also indicates that the re are no substantial increases between FG72 and conventional soy

bean ( Rouquié et al., 2010 ) . The general public may

come into contact with gl yphosate and IFT used in the cultivation of GH72 soy

bean. Based on information provided in existing APHI S EAs ( USDA - APHIS, 2012a) , the potential human health risks associated with glyphosate use is expected to be similar to the No Action Alternative. Members of the general public are unlikel y to come into direct exposure with IFT as a result of a

pplication. As a restricted - use pesticide, IFT is not registered for residential use and may

only be applied by

certified applicators or under the direct supervision of a certified applicator, thus mitigating potential exposure to IFT prior to harvest ( EPA, 2011b , 2012b ) . Furthermore, EPA has included use restrictions on the IFT label to mitigate potential exposure to IFT (Appendix A). EPA recently established combined to lerances for IFT and DKN on soy bean and aspirated soy

bean grain fractions following a human health risk assessment (Appendix A) ( EPA, 2011c ) . As a result of this human health risk assessment, EPA concluded that there are no residue chemistry , toxicological, or occupational/residential exposure i ssues that would preclude the establishment of an unconditional registration or permanent tolerances for IFT and DKN on so ybean and aspirated so yb ean grain fractions ( EPA, 2011c ) . Establishment of a tolerance for IFT on soybean concludes that there is a reasonable certainty that no harm to human health will result from aggregate exposure to IFT or its residues, including all dietary exposures and all other exposures for which there is reliable information ( 76 FR 235, 2011 ) . When used according with EPA label restrictions, the established tolerances of IFT on so yb ean and aspirated so yb ean grain f ractions are unlikel y to adversel y affect human health. **4.6 Animal Feed**  No Action Alternative: Animal Feed The majority of the soybean cultivated in the U.S. is grown for animal feed and is usually fed as soybean meal . Under the No Action Alternative, soy bean - based animal feed will still be available from currently

cultivated conventional varieties, including GE soy bean varieties that are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act . This includes herbicide - tolerant GE soy bean varieties. No change in the availability of these crops as animal feed is expected under the No Action Alternative.4 8

Preferred Alternative: Animal Feed Under FFDCA, it is the responsibility of feed manufactur ers to ensure that the products they market are safe and properly labeled. Feed derived from FG72 so yb ean must be in compliance with all applicable legal and regulatory requirements. GE organisms for feed may undergo a voluntary consultation process with the FDA prior to release onto the market. Bayer CropScience initiated the consultation process with FDA for the commercial distribution of FG72 so ybean and submitted a safety and nutritional assessment of food and feed derived from FG72 so ybean to the FD A on December 3 , 2009 . FDA is currentl y evaluating the submission, and as of March 16 , 201 2 , has not completed the consultation. A determination of nonregulated status of FG72 soy bean is unlikely

to adversely

affect the nutrition of animal feed, and thus, animal health. The two introduced proteins in FG72 soy bean, 2mEPSPS and HPPD W336, are unlikel y to substantially affect the nutritional quality of so yb ean meal derived from FG72 soy bean. 2mEPSPS has been previousl y anal yz ed and approved by several inter

national regulatory

agencies, demonstrating that it is not likely to have any significant impact on animal health ( CFIA, 1998 ; FSANZ, 2001 ; SCF, 2002 ; USDA - APHI S, 1997 ) . Though HPPD W336 has not previously been evaluated in animal feed, there is no reason to suspect it would present a substantial risk to animal health. HPPD proteins are ubiquitous in the environment. Additionally , bioinformatic analy sis of HPPD W336 showed no significant lengthwise alignment with known toxins or allergens ( Baye r, 2011c ) . With regard to FG72 so ybean itself, compositional analysis revealed no substantial differences between it and conventional soy bean in factors important for animal feed, such as proximate and fiber components, amino acid and fatty acid content, and antinutrients and isoflavone concentrations ( Bayer, 2011c ) . Consequentl y, the quality of animal feed derived from FG72 soy bean is unlikely

to be substantially

different than animal feed produced from current so yb ean varieties. **4.7 Socioeconomic Impacts**  4.7.1 Domestic Economic Environment No Action Alternative: Domestic Economic Enivonrment In 2010, 76 million acres of soy beans were cultivated in the U.S., yielding 3.3 billion bushels at a value of 38.9 billi on U.S. dollars (USDA -NASS, 2011c ) . The majority of soybeans produced in the U.S. is utilized domestically for animal feed, with less amounts and by products used for oil or fresh cons umption ( GI NA, 2011 ; USDA - ERS, 2010b ) . Under the No Action Alternative, FG72 so ybean and its progen y would remain regulated under 7 CFR part 340. Growers and other parties who are involved in production, handling, processing, or consumption of soy

bean would no t have access to FG72 so ybean and its progen y, but would continue to have access to conventional soy bean varieties, including GE soy bean varieties that are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest49

provisions of the Plant Protection Act . Domestic growers will continue to utilize conventional soy bean varieties based upon availability and market demand. Preferred Alternative: Domestic Economic Environment Soy bean composition greatly affects its viability

as a compon ent of animal feed. So ybean meal generall y contains 50 percent protein b y dry weight and is an important component of soy bean production. An additional 19 percent (b y weight) of domestically chorused soybeans are used to produce oil (USB, 2011 ) . The fatt y acid content of soybean grain is important for the do mestic soy bean oil industry , as the soy bean oil profile affects melting point, oxidative stability , and chemical functionality , ultimately determining the market value/marketability of the product ( APAG, 2011 ) . A determination of nonregulated status of FG72 soy bean is expected to have similar impacts on the domestic economic environment as the No Action Alternative. Paired comparison of FG72 soy bean with its nontransgenic, parent variety demonstrated n o significant differences in fatty acid or crude protein content ( Figure 9). Thus, market sector use of FG72 soy bean under the Preferred Alternative is unlikely to be substantially

different from market use of Jack, as the primary factors of oil and prote in content are not substantially different between the two so yb ean varieties.

**Figure 9**  **.** Comparison of ty pical so ybean fatty acids and crude protein between FG72 so ybean and Jack. Source: Bayer ( 2011c ) .50

4.7.2 Trade Economic Environment No Action Alternative: Trade Economic Environment The U.S. produces approximately 35 percent of the global soy bean suppl y ( Soy

Stats, 2011c ) . In 2010, the U.S. exported 1.6 billion bushels of soy bean, which account ed for 44 percent of the world's so yb ean exports ( Soy Stats, 2011b ) . The global demand for so ybeans is expected to increase b y a full third over 2010 consumption in the next ten year s. China is expected to account for 80 percent of the increase d demand ( FAPRI , 2009 ; Hartnell, 2010 ) . China and India are predicted to import 46 percent of the total soybean market by 2018/2019 ( FAPRI, 200 9 ) . The USDA has predicted that U.S. exports will remain flat during much of this period, as a result of increase in domestic consumption and competition from South America ( FAPRI, 2009 ; USDA - ERS, 2009 ) . Under the No Action Alternative, there is unlikely to be any change to the current so ybean market. Most (93 percent) of the so ybean varieties currentl y cultivated in the U.S. are GE varieties and it is predicted that this will not change substantiall y (USDA - ERS, 2011a) . U.S. soy beans will continue to play a role in global so ybean production, and the U.S. will continue to be a supplier in the international market. Preferred Alternative: Trade Economic Environment FG72 so ybean is not likely to adversel y impact the U.S. trade economic environment and may have a positive impact through increased yi elds in soy bean areas affected by

gly phosate - resistant weeds. To support commercial introduction of FG72 soy bean in the U.S., Bayer CropScience inte nds to submit dossiers to request import approval of FG72 so yb ean to the proper regulatory authorities of several countries that already have regulatory processes for GE soy

bean in place. These include, but is not limited to: Canada, Mexico, Japan, the EU , South Korea, and China ( Baye r, 2011c ; Coates, 2012 ) . In general, a global launch (i.e., commercialization) may not be undertaken until the proper regulatory approvals have been obtained ( Coates, 2012 ) . Approval in these export countries is intended to mitigate global sensitivities to GE productions and work in accordance with international regulations. The trade economic impacts associated with a determination of nonregulated status of FG72 so yb ean are anticipated to be very similar to the No Action Alternative.51

**5 CUMULATIVE IMPACTS**  A cumulative impact may be an effect on the environment which results from the incremental impact of the p roposed a ction when added to oth er past, present, and reasonably foreseeable future actions. For e xample , this may include the potential effects associated with a determination of nonregulated status of a GE crop in combination with the future production of crop seeds with multiple trai ts that are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. A cumulative impact may also include the use of a pesticide with a similar mode of action to that of the intended pesticide described in the petition for nonregulated status. **5.1 Assumptions Used for Cumulative Impacts Analysis**  Stacked so ybean varieties may contain more than one GE trait as the result of crossing two GE soy bean plants. Under the Preferred Alternative , FG72 s oy bean may be crossed with non - GE or GE soy bean varieties that are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act (USDA - APHI S, 2012a) . APHIS regulations at 7 CFR Part 340 do not provide for Agency oversight of GE soy

bean varieties no longer subject to the requirement of Part 340 and the plant pest provision s of the Plant Protection Act, or ov er stacked varieties combining these GE varieties, unless it can be positively shown that such stacked varieties were to pose a likely plant pest risk. With regard to FG72 soy bean, there is no indication in the Bayer CropScience FG72 soy bean petition or i nternational import approval application packages that FG72 soy bean will be stacked with any specific GE or non GE soy bean trait ( Baye r, 2011c ; EFSA, 2011b ; FSANZ, 2011a) . Even with regard to possible stacking with Bayer CropScience’s glufosinate - tolerant soy bean ( 98 - 238 - 01p and 96 - 068 - 01p ), there exists uncert ainty in the development of that particular product, as glufosinate is described as a potential herbicide to control volunteer FG72 soy bean in the Bayer CropScience petition ( Baye r, 2011c ) . T here is no assurance that FG72 soy bean will be stacked with any particular GE or non - GE soy

bean trait, as company

plans and market demands play a major role in those business decisions . Therefore, predicting all potential combinations of stacked varieties from current GE and non - GE so ybean varieties is hypothetical and speculative. With regard to foreseeable herbicide use in U.S. soybean production, it is reasonable to assume that FG72 so ybean will also confer tolerance to other herbicides that, like IFT, function as HPPD inhibitors. Inparticular, mesotrione represents an herbicide that may be applied on FG72 soy bean ( Bay News, 2011 ) . Mesotrione, developed by S yn genta, is commonly

marketed under the Callisto ® trade name. In 2009, the EPA established a tolerance for residues for mesotrione on soy bean seed ( 74 FR 67119 ) . EPA also amended the original Callisto ® registration label to allow for a mesotrione - tolerant soy bean at pre - emergent app lication rate of 0.188 lbs. a.i./acre ( EPA, 2009b ; Sy

ngenta, 2011 ) . **5.2 Cumulative Impacts: Acreage and Range of Soybean Production**  Cumulative effects resulting from a determination of nonregulated status of FG72 so ybean on acreage and range of so ybean production are unlikely . GE so yb ean vari eties already constitute a large proportion of U.S. soy bean production (93 percent) (USDA - ERS, 2011a) ; cultivation of52

FG72 so ybean with current GE soy bean varieties is unlikely

to substantially change this pattern of adoption , as it represents a replacement and not supplemental soy bean variety for U.S. soy bean growers. Acreage of so yb ean production is primarily dependent on market demand; cultivation and associated production practices of FG72 so ybean are unlikely to disrupt this causal relationship, as U.S. soy

bean production is strongl y affected b y market demand, not b y any one so yb ean variety (USDA - ERS, 2010b , 2011c ) . Furthermore, the range of so ybean cultivation is unlikely to be impacted b y a determination of nonregulated status of FG72 so ybean. FG72 soy bean generall y does not present an absolute yield gain under standard management conditions and does not display

a phenoty

pe that would be indicative of an improved capacity to grow outside an agricultural environment (USDA - APHIS, 2012b ) . Similar to currentl y - available so yb ean varieties, FG72 so ybean is likely to require cultivation on high quality arabl e land to be profitable . Consequentl y, FG72 so ybean is unlikely to encourage cultivation on marginal land, thus maintaining currently - observed farm - level land - use decisions to shift agricultural land away from other crops, such as cotton or hay , toward so yb ean production to satisfy market demand (USDA - ERS, 2010e , 2011c ) . **5.3 Cumulative Impacts: Agronomic Practices**  Agronomic practices related to soy bean production are often dependent on the particular soy bean variety cultivated. FG72 soybean possesses similar agronomic requirements and pest sensitivities as conventional soy bean, and thus, is not anticipated to have any cumulative effect on current and general soy bean agronomic practices, such as fertilization, ro tational, and pesticide application practices (USDA - APHI S, 2012b ) . Farmers that grow FG72 soy bean may appl y gl yp hosate, IFT, and/or mesotrione. Gly phosate is already applied on the majority of U.S. soy

bean acreage (NRC, 2010 ) . Therefore, cultivation of FG72 so ybean is unlikely to change current gl yphosate use pattern s, so no cumulative effects on agronomic practices are likely . A determination of nonregulated status of FG72 soy bean may permit the use of 4 - HPPD inhibiting herbicides beyond IFT. Mesotrione, like IFT, is a broad spectrum herbicide that may be used to c ontrol a variety of broad - leaf weed species ( Sy ngenta, 2011 ) . Additionally , mesotrione, like IFT, may be applied pre - emergence to FG72 soy bean ( 74 FR 67119 ; Bay News, 2011 ) . Application of IFT and/or mesotrione over FG72 soy bean is unlikely to result in an y cumulative effect on current conservation tillage practices because both herbicides can be applied during a similar application window and provide control over a similar range of weed species ( Bayer, 2011b ; Sy ngenta, 2011 ) . Furthermore, application of mesotrione, like IFT, does not result in common corn rotational restrictions ( Bayer, 2011b ; Sy ngenta, 2011 ) . Application of mesotrione over FG72 so ybean may result in a net herbicide use increase in U.S. soy bean production, as mesotrione was onl y recently registered for use in soybean ( 74 FR 67119 ) . This net increase, however, may not be substantially

higher than anticipated increases in soy bean herbicide use described in Sections 2.1.2 and 4.2.2 . Using corn production as an example of mesotrione use trends, mesotrione use was substantially less than that of glyphosate between 2001

– 201 0, and represented onl y three percent of total gl yphosate application in 2010 ( Table 1 1) (USDA -NASS, 2 011a) . Application in soy bean may not be as high as corn due to restrictions in application time. In corn, mesotrione may be applied pre - or post - emergence; in53

soy bean, however, mesotrione is only labeled for pre - emergent use ( Sy ngenta, 2011 ) . Additionally , the maximum application rate of mesotrione in soy bean is less than that of corn (6.0 fl. oz., versus 7.7 fl. oz. respectivel y). Conseque ntly , mesotrione use in soy bean may be less than that of corn, due to a more restricted application window and annual use rate. Taken in total, application of IFT or mesotrione in FG72 soybean is unlikely to result in a cumulative effect on herbicide use, as restrictions in use, reduced application rate, and residual control post application of both herbicides may limit use of both herbicides relative to gly phosate in so ybean production sy stems. **Table 11**  **.** Use of gl yphosate and meso trione in U.S. corn production, 2001

– 2010. Year Glyphosate

application in corn

- Measured in total lbs. Average glyphosate

application in corn - Measured in total lbs./acre Mesotrione

application in corn - Measured in total lbs. Average mesotrione

appl ication in corn - Measured in total lbs./acre 2010 57,536,000 0.82 1,693,000 0.121 2005 22,967,000 0.73 1,853,000 0.119 2003 11,913,000 0.69 976,000 0.1 2002 3,307,000 0.64 367,000 0.09 2001 6,868,000 0.66 7,000 0.09 Source: USDA -NASS ( 2011a) . **5.4 Cumulative Impacts: Organic Soybean Production**  A determination of nonregulated status of FG72 soy bean is unlikely

to have a cumulative effect on organic so ybean production. FG72 so ybean, like other so ybean varieties, is primarily a selfpollinated crop (USDA - APHI S, 2012b ) . There is no reason to suspect that the biology of FG72 soy bean will increase its potential to outcross with soy bean varieties utilized in organic so ybean production because field studies revealed no substantial differences in factors influencing reproductive potential, including pollen viability , date of emergence, date of 50 percent flowering, and date of maturity ( USDA - APHIS, 2012b ) . Despite incr easing demand for organic soy bean products and commodities, U.S. production of organic so ybean is unlikely to keep pace (USDA - ERS, 2010c ) . It is unlikely that FG72 soy

bean will substantially

affect this trend. Reasons for the inability of domestic organic soy

bean production to meet demand include: 1) the three - year period transition period between conventional and organic farming; 2) a lack of contractors for organic agronomic practices, including pest and nutrient management; 3) intensive labor re quirements; 4) fear of criticism from neighbors; 5) an absence of government infrastructure and policy support; and 6) unknown risks ( Clarkson, 2007 ; USDA - ERS, 2007 ) . The increased demand for organic soybean in the U.S. has generally

been met by

increasing imports from international organic soy bean producers ( The Organic & Non - GMO Report, 2007 ; USDA - ERS, 2007 ) .54

**5.5 Cumulative Impacts: Soil Quality**  A determination of nonregu lated status of FG72 soy bean is unlikely

to result in a cumulative impact on soil quality . Comprehensive phenotypi c, agronomic, and ecological assessments conducted b y the petitioner for FG72 so ybean did not find substantial differences between FG72 soy be an and control soy

beans for these characteristics ( Baye r, 2011c ) . The few differences that were identified were typically small, site specific, and unlikely to be biologically meaningful. Event FG72 so ybean required simi lar agronomic practices as non - GE so yb ean ( Baye r, 2011c ) . Consequently , the phenoty pic, agronomic, and ecological data presented in the Bayer petition support the conclusion by APHIS that FG72 so yb ean will not substantial ly modify soil characteristics associated with ty pical so ybean production practices. In particular, FG72 soybean will permit the continued trend of conservation tillage, an agricultural practice with strong direct and positive effects on soil quality ( Holland, 2004 ; NRC, 2010 ) . Farmers that grow FG72 soy bean may appl y gl yp hosate, IFT, and/or mesotrione. Gly phosate is alre ady applied on the majority of U.S. soy

bean acreage (NRC, 2010 ) . Therefore, cultivation of FG72 so ybean is unlikely to change current gl yphosate use patterns, so no cumulative effects on soil quality

are likel y. Mesotrione may be applied pre - emergence to FG72 soy bean production fields. Li ke IFT, mesotrione is a 4 - HPPD inhibitor. Mesotrione does not persistent in soil, as indicated b y photolysis, aerobic and anaerobic soil metabolism, and field dissipation studies ( EPA, 2001b ) . An y impact directl y from soil quality as a result of mesotrione application is most likely

to affect rotational crops that may be planted sometime after mesotrione application. Fo r this purpose, rotational restrictions are described on the EPA use label, indicating which crops are safe to plant ( Sy ngenta, 2011 ) . The pres ence of these rotational restrictions is not inherently

any different than rotational restrictions with currentl y used so yb ean herbicides. **5.6 Cumulative Impacts: Water Resources**  A determination of nonregulated status is unlikel y to result in a cumulative impa ct on water resources related to soy

bean production. This conclusion is based on the fact that cultivation of FG72 so ybean is likely to permit the continued use of conservation tillage, and thus, maintain its indirect and positive effects on water quality and runoff. T he agronomic performance of FG72 soy bean is similar to conventional soy bean , suggesting that FG72 so yb ean does not require more irrigation than currently - available soy bean varieties ( Bayer, 2011c ; USDA - APHI S, 2012b ) . Farmers that grow FG72 soy bean may appl y gl yp hosate, IFT, and/or mesotrione. Gly phos ate is already applied on the majority of U.S. soy

bean acreage. Therefore, cultivation of FG72 soy bean is unlikely

to change current gl yphosate use patterns, so no cumulative effects on water quality are likel y. IFT and mesotrione are not anticipated to result in an y cumulative effect on water quality, because they do not persist in soil or aqueous environments ( EPA, 2008 , 2011d) . Furthermore, while both IFT and mesotrione may be mobile in water, the leaching potential of each compound is not substantially greater than current herbicides commonly utilized in soy

bean production, suggesting that they pose no greater leaching risk to water resources (NY State IPM Program, 2012a , 2012b ) .55

**5.7 Cumulative Impacts: Air Quality**  APHI S has not identified any cumulative effects for this issue resulting from a determination of nonregulated status of FG72 soy bean. APHIS does not anticipate any substantial changes in soy bean production practices or an expansion of soy bean acreage as a result of a determination of nonregulated status of FG72 so ybean. Agricultural practices will continue to have the potential to cause negative impacts to air quality . Agricultural emission sources will co ntinue to include smoke from agricultural burning, tillage, traffic and harvest emissions, and nitrous oxide emissions from the use of nitrogen fertilizer. These agricultural emissions sources are anticipated to be similar between conventional soy bean varieties and cultivation of FG72 soy bean. **5.8 Cumulative Impacts: Climate Change**  APHI S has not identified any cumulative effects on climate change following a determination of nonregulated status of FG72 soy bean. APHIS does not anticipate any substantial change s in soy bean production practices or an expansion of soy bean acreage as a result of a determination of nonregulated status of FG72 so ybean. The consequences of the Preferred Action Alternative on commercial so ybean production and acreage are the same as f or the No Action Alternative. It is possible that climate change may affect soy

bean cultivation areas in the U.S. For example, as projected b y the U.S. Global Change Research Program ( 2009 ) , the northern regions of the Great Plains may

become wetter while the southern regions may become drier. However, these shifts are unlikel y to uniquely affect FG72 so ybean, as there is no reasonable expectation that this soy bean variety would require less moisture or possess a cultivation range that is different than conventional soy

bean. **5.9 Cumulative Impacts: Animal Communities**  Under field conditions, soy b ean or soy

bean grain may

be used by

mammals, birds, or arthropods. Baye r CropScience data demonstrates that the composition of FG72 soy bean does not substantially

differ from conventional soy bean varieties (USDA - APHIS, 2012b ) . Both APHIS and Food Standards Australia New Zealand (FSANZ) have concluded that FG72 so ybean is compositionally

similar to conventional soy bean ( FSANZ, 2011a ; USDA - APHI S, 2012b ) . This indicates that FG72 so yb ean is unlikely to result in a cumulative effect on animal communities through consumption. Pesticides are applied on a majority of U.S. soy

bean acres, with herbicides representing the majority of pesticide applications (NRC, 2010 ; USDA -NASS, 2007 ) . Nontarget insects are unlikely to be substantially

affected by

insecticide application practices in FG72 so ybean compared to conventional soy bean, as insecticide application patterns are similar between FG72 and conventional so ybean (USDA - APHIS, 2012b ) . Farmer s that grow FG72 soy bean may appl y gl yp hosate, IFT, and/or mesotrione. Gly phosate is already applied on the majority of U.S. soy

bean acreage (NRC, 2010 ) . Therefore, cultivation of FG72 so ybean is unlikely to change current gl yphosate use patterns, so no cumulative effects on animals are likel y. The potential pre - emergent application of mesotrione to FG72 so ybean is not anticipated to cause a cumulative effect on animal communities because mesotrione is practically56

non - toxic to birds, small mammals, fish, daphnids and relativel y non - toxi c to honey bees ( EPA, 2001b ) . This is effectively similar to the environmental fate of IFT, which poses little risk to bi rds, mammals, fish, and the honey bee ( EPA, 2011b , 2011d) . **5.10 Cumulative Impacts:**  **Pl ant Communities**  A determination of nonregulated status of FG72 soy bean is unlikely

to have any

cumulative effect on plant communities beyond what is already occurring in soy

bean production. The introduced proteins in FG72 soy bean, 2mEPSPS and HPPD W336 , are derived from organisms that are non - pathogenic and/or non - toxic to plants; these proteins are effectively benign in the environment ( Bayer, 2011c ) . There are no wild relatives of soy bean in the U.S. This eliminates any gene transfer between FG72 and non - domesticated plants ( OECD, 2010 ) . Furthermore, FG72 so ybean does not display weedy characteristics and is not expecte d to be a weed (USDA APHI S, 2012b ) . Cultivation of FG72 soybean will permit the use of gl yphosate, IFT, and/or mesotrione to control weed populations. Gl yp hosate is already widel y applied in U.S. soy bean production fields ( Bonn y, 2011 ; NRC, 2010 ; USDA -NASS, 2007 ) . Since FG72 so ybean is tolerant to gl yphosate, it is unlikely

to disrupt current gl yphosate use patterns and its effect on plant communities. IFT and mesotrione are broad - spectrum herbicides that have not previousl y been utilized in soy bean production. Both IFT and mesotrione share control characteristics of common weed species (Figure 10 ). Mesotrione demonstrates a smaller range in controll able weed species than IFT, primarily

due to less effective grass weed control ( Sy ngenta, 2011 ) . However, mesotrione, like IFT, represents another herbicide in a growing diversity of herbicides utilized in soy bean production and is not likely to result in a cumulative impact on weed species relative to other herbicides currentl y utilized in U.S. soy bean production. Runoff of IFT or meso trione may pose an environmental risk to non - target plants ( EPA, 2001b , 2011d) . However, runoff is a risk associated wi th any broad - spectrum herbicide and is not unique to IFT or mesotrione. As a consequence of its registration, EPA has determined that there is no unreasonable environmental risk if end users adhere to the EPA label directions when applying IFT or mesotrio ne herbicide formulations on soy beans. Violators of the regulations are liable for all negative consequences of their actions. This imposes an added incentive on farmers use IFT and/or mesotrione to follow EPA label use restrictions. Weed populations c an change in response to farm - level agronomic practices, including weed management decisions. Cultivation of FG72 soybean may provide some utility

in the control of gl yphosate - resistant weeds because IFT and mesotrione represent broad - spectrum herbicides with an alternative MoA. With respect to gl yphosate - resistant weeds that may be found in U.S. soy bean fields, mesotrione provides a more limited spectrum of control, primarily due to its ineffectiveness against grassy weeds (Table 12). By

possessing an a lternative MoA, mesotrione can be expected to control kochia, Palmer amaranth, common and giant ragweed, and common waterhemp ( Sy

ngenta, 2011 ) .57

**Figure 10**  **.** Weed control provided by herbicides isoxaflutole (IFT) and mesotrione. In contrast to isoxaflutole, mesotrione does not generall y provide control of weedy grasses Sources: Bayer ( 2011b ) and S yn genta ( 2011 ) .

**Table 12**  **.** Gly

phosate - resistant weed (in so ybean fields) control profiles for isoxaflutole (IFT) and mesotrione. **Broadleaf Weeds*** **Isoxa flutole**  **control/suppression Mesotrione** 

**control/suppression** Horseweed (Marestail) ( Conyza candensis ) Yes No Kochia ( Kochia scoparia ) Yes Yes Palmer Amaranth ( Amaranthus palmeri ) Yes Yes Common ragweed (Ambrosia artemisiifolia ) Yes Yes Giant ragweed ( A mbrosia trifida ) Yes Yes Common waterhemp ( Amaranthus tuberculatus ) Yes Yes Goosegrass ( Eleusine indica ) Yes No Italian ryegrass ( Lolium spp. multiflorum ) Yes No Johnsongrass ( Sorghum halepense ) Yes No *Only certain weed populations demonstrate gl yp hosate resistance. Sources: Bayer ( 2011b ) and Syngenta ( 2011 ) .58

Since 2009, four populations of common waterhemp in I llinois, I owa, and Nebrask a were reported to be resistant to 4 - HPPD inhibitors ( Heap, 2011b ) . Despite the four reported cases, only one waterhemp population (Mclean County , IL) was studied in detail ( Hausman et al., 2011 ; Sy ngenta, 2010 ) . In the Mclean Count y population (which also possessed non - target site atrazine resistance), development of 4 - HPPD resistance was generall y linked to seed corn production and its respective management strategies that precluded the application of pre emergent and broad - spectrum herbicides. As a result, 4 - HPPD inhibitors were used with out MoA rotation over the course of seven growing seasons (2003

– 2009) ( Hausman et al., 2011 ) . Further examination of this waterhemp population revealed that control could be achieved through several co mmon agricultural strategies, including the pre - emergent application of 4 - HPPD inhibitors and post - emergent foliar application of broad - spectrum herbicides, such as gl yphosate and glufosinate ( Sy ngenta, 2010 ) . While the Mclean County population of waterhemp demonstrated that the development of resistance to 4 - HPPD inhibitors is possible, it also underscored the value of herbicide chemistry rotation (alternative MoA) acros s growing seasons and the utility of pre - emergent herbicide application in weed control. Effective management, however, does not ensure that herbicide use is intrinsically

sustainable. Herbicide use (and indirectly , the use of herbicide - tolerant crops) i s sustainable only

as a component of a broader integrated weed management sy stem ( Mortensen et al., 2012 ) and that the preemptive incorporation of integrated weed management measures may prevent or mitigate the development of a resistant weed population ( Baye r, 2011c ) . Agricultural weed development is not necessarily limited to herbicide use, but may also develop in response to cultural methods not reliant on herbicide use ( Vaughan et al., 2008 ) . Thus, integrated weed management does not exclude an y one management technique. It incorporates a number of practices, including the use of cover and rotational crops, tillage, and herbicide applications to reduce selection pressure and weed populations in an agroenvironment ( Mortensen et al., 2012 ) . As part of its integrated weed management plan for FG72 so ybean, Baye r has proposed the following in its stewardship of FG72 so ybean:  Correctl y identify weeds and look for trouble areas within field to identify resistance indicators;  Rotate crops;  Start the growing season with clean fields;  Rotate herbicide MoA b y using mul tiple MoAs during the growing season and appl y no more than two applications of a single herbicide MoA to the same field in a two - year period. One method to accomplish this is to rotate herbicide - tolerant trait sy stems;  Apply recommended rates of herbicid es to actively growing weeds at the correct time with the right application techniques;  Control any

weeds that may

have escaped the herbicide application; and  Thoroughl y clean field equipment between fields ( Baye r, 2011c ) . Cultivation of FG72 soybean may potentiall y allow a more comprehensive approach to weed management. Crop and herbicide rotation are two factors that may mitigate the development of herbicide resistance in weeds. As stated previously in this EA, there is reason to believe that59

FG72 so ybean would benefit from crop rotation (similar to commercial soybean varieties), and that FG72 so ybean would permit the use of two herbicides with different MoAs, followed b y use of an alternative MoA in the next growing sea son (e.g., glufosinate). Utilized within an integrated weed management sy stem and within the context of best management practices, a determination of nonregulated status of FG72 so yb ean may positively

contribute to the control of gl yphosate - resistant weed populations while also reducing the development of other herbicide resistance. **5.11 Cumulative Impacts: Gene Flow and Weediness**  As described in the USDA - APHIS PPRA for FG72 soy bean , no substantial differences are observed in pollen viability , pollen morphology , or seed dormancy ( Baye r, 2011c ) . Consequently , the barriers that exist between different soy bean varieties and sexually - compatible soy bean varieties would likely continue to act as limitations on gene flow without any c umulative effect on gene flow. The soy bean industry

has identity

protection (IP) measures in place to restrict pollen movement and gene flow between so ybean fields through the use of isolation distances, border and barrier rows, the staggering of planting dates and various seed handling, transportation, and cleaning procedures ( Bradford, 2006 ; NCAT, 2003 ; Sundstrom et al., 2002 ) . Furthermore, FG72 so ybean represents a domesticated so ybean variety that would not be anticipated to survive outside the agricultural environment, indicating that cultivation of FG72 soy bean may not result in a cumulative effect on plant weediness. **5.12 Cumulative Impacts: Microorganisms**  Cultivation of FG72 soybean is unlikely to have a cumulative effect on soil microorganisms relative to the cultivation of conventional soybean vari eties, including GE soybean varieties that are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. Microbial activity in agricultural soil is often strongly dependent on cultivation conditions, with the primary effectors representing crop type, seasonality, prevalent soil properties, and tillage strategy (Hart et al., 2009 ; Holland, 2004 ) . When generally compared to existing soybean production practices, cultivation of FG72 will utilize similar management conditions, such as the continuation of conservation tillage, seasonal rotation of s oybean with additional crops, and broad use of herbicides. In particular, the majority of U.S. soybean acres are sprayed with glyphosate and other herbicides. FG72 soybean will permit the continuation of this existing trend, as it will permit the application of glyphosate and IFT. Because any microorganism is already extensively exposed to herbicides in current U.S. soybean production fields, it is unlikely that any new microorganism would be affected through production practices associated with FG72 soy bean or its progeny. For example, a determination of nonregulated status of FG72 soybean may result in the pre emergent application of mesotrione. Toxicity of mesotrione at recommended field application rates, however, is generally not toxic to microorganisms or any more toxic than commonly applied agricultural herbicides ( Bonnet et al., 2008 ; Crouzet et al., 2009 ) . **5.13 Cumulative Impacts: Biodiversity**  Cultivation of FG72 soybean is unlikely to have toxic effects on non - target animals and microorganisms. Additionally , cultivation of FG72 soy bean is likely

to be neutral with regard to60

biodiversity

compared with ty

pical GE and non - GE soy bean production systems, due to similar management conditions for both production sy stems. Application of herbicides in U.S. soy bean production will continue to be dictated b y both individual farm need and EPA label use restrictio ns. As a consequence of its herbicide registration program, EPA has effectivel y determined that there is no unreasonable environmental risk if the end user adheres to the directions and restrictions on the EPA registration label when appl yi ng herbicide fo rmulations . When required, application by a certified applicator further minimize s effects on biodiversity . Since v iolators of requirements are liable and can be held legall y accountable for all negative consequences of their actions , this responsibility serves as an additional safeguard against any adverse cumulative effects on non - target organisms and biodiversity from the use of EPA restricted use pesticides. The use of GE so yb ean varieties containing herbicide - tolerant trait s may improve biological di versity by providing growers the opportunity to use conservation tillage practices ( Bonn y, 2011 ; NRC, 2010 ) . Incorporation of herbicide tolerance in the crop facilitates the grower adoption of conservation and no - till strategies, improved soil porosity , enhancing soil fauna and f lora ( CTIC, 2010 ) , increasing the flexibility of crop rotation, and facilitating strip cropping ( Fernandez - Cornejo et al., 2002 ) . Each of these contributes to the health of the faunal and floral communities in and around soy bean fields thereby

promoting biodiversity ( Palmer et al., 2010 ) . **5.14 Cumulative Impacts: Human Health**  A determination of nonregulated status of FG72 soy bean is not anti cipated to result in any cumulative effect on human health. FG72 so yb ean is compositionally equivalent to conventional soy bean (USDA - APHIS, 2012b ) . Therefore, consumption of FG72 soy bean is expected to be as safe as consumption of conventional soy bean. FSANZ has already determined that FG72 soy bean is as whole and nutritious as conventional soy bean ( FSANZ, 2011a , 2011b ) . Farmers that grow FG72 soy bean may appl y gl yp hosate, IFT, and/or mesotrione. Gly phosate is already applied on the majority of U.S. soy

bean acreage (NRC, 2010 ) . Therefore, cultivation of FG72 so ybean is unlikely to change current gl yphosate use patterns, so no cumulative effects on human health are likely . Human exposure to IFT or mesotrione, either indirectl y through residue on soy bean grain or directly

through soy

bean production in the field, is no t expected to result in a cumulative impact on human health. Pesticide tolerances have been established for both IFT and mesotrione on soy

bean, so no unnecessary

risk to human health from residues resulting from application at approved labeled use rates are anticipated ( 74 FR 67119 ; 76 FR 235 ) . Human health risk assessments for IFT and mesotrione have generally indicated that both herbicides pose no unnecessary

risk to human health ( EPA, 2009b , 2011c ) . Additionally , registration and application of these pesticides will also continue to be regulated b y EPA, ensuring that there is no unnecessary

risk for both the general public and agricultural workers. **5.15 Cumulative Impacts: Animal Feed**  FG72 so ybean is not anticipated to result in any cumulative effect on animal feed. The introduced proteins in FG72 soy bean are not toxic or alle r gi c. Since the composition of FG72 is similar to conventional soy bean varieties, this also serves as a good indicator that negative effects on feed quality containing FG72 soy bean grain are unlikely ( Bayer, 2011c ) . FSANZ has61

already determined that FG72 so ybean is as whole and nutritious as conventional soy bean ( FSANZ, 2011a , 2011b ) . Farmers that grow FG72 soy bean may appl y gl yp hosate, IFT, and/or mesotrione. Gly phosate is already applied on the majority of U.S. soy

bean acreage (NRC, 2010 ) . Therefore, cultivation of FG72 so ybean is unlikely to change current gl yphosate use patterns, so no cumulative effects on animal feeds are likel y. Animals may be exposed to IFT or mesotrione through residue on soy bean grain that is added to animal feed. This exposure route is not expected to result in a cumulative impact on animal health. Pesticide tolerances have been established for both IFT and mesotrione on soy

bean, so residues resulting from application at recommended rates are not anticipated to pose an y unne cessary risks ( 74 FR 67119 ; 76 FR 235 ) . **5.16 Cumulative Impacts: Domestic Economic Environment**  Domestically- produced soy bean and so yb ean produ cts are produced for a number of markets. Market use of so yb ean is often dependent on the soy bean variety , and thus composition, produced. There are compositional differences among some soy bean varieties grown for animal feed and those for human consumpt ion . These include those soy bean varieties that are intentionally

produced to yield a modified fatt y acid profile. They may include soy

beans that have been produced through standard breeding or GE methods. With regard to these modified oil soy bean varie ties, the soy

bean industry

already utilizes identity

protection measures to restrict pollen movement and gene flow between so ybean fields through the use of mitigations such as isolation distances, border and barrier rows, the staggering of planting dates and various seed handling, transportation, and cleaning procedures ( Bradford, 2006 ; NCAT, 2003 ; Sundstrom et al., 2002 ) . FG72 so yb ean is compositionally similar to its non - GE comparator, Jack ( Bayer, 2011c ) . Thus, market use of FG72 soy bean should be similar to that of Jack. With regard to ensuring the quality

of soy bean animal feed, because of the general absence of plant reproductive attributes that could affect gene flow, it is unlikely that FG72 soy bean would present an y additional issue beyond those already disc ussed for conventional so ybean varieties. **5.17 Cumulative Impacts: Trade Economic Environment**  Although the primary

U.S. soy bean export destinations do not present major barriers to trade in GE products, Bayer CropScience would need to obtain FG72 so ybean approv al in destination countries before commercialization in the U.S. to avoid adversely affecting current trade flows. Requests for approvals have been submitted to several markets, including , but is not limited to, Canada, Mexico, Japan, the EU, South Korea, and China . Bayer CropScience has previously stated its intention to seek approval for FG72 so ybean in primary U.S. export destinations with functioning regulatory

s ystems before commercialization in the U.S. ( Coates, 2012 ) . Thus, a cumulative effect on the trade economic environment is not anticipated following a determin ation of nonregulated status of FG72 so yb ean, because it is unlikely to be commercialized until it is approved for export to major U.S. soy bean importing countries.62

**6 THREATENED AND ENDAN**  **GERED SPECIES** Congress passed the Endangered Species Act (ESA) of 197 3, as amended, to prevent extinctions facing man y species of fish, wildlife and plants. The purpose of the ESA is to conserve endangered and threatened species and the ecos ys tems on which they depend as key

components of America’s heritage. To implement the ESA, the U.S. Fish & Wildlife Service (USFWS) works in cooperation with the National Marine Fisheries Service (NMFS), other Federal, State, and local agencies, Tribes, non - governmental organizations, and private citizens. Before a plant or animal speci es can receive the protection provided by the ESA, it must first be added to the Federal list of threatened and endangered wildlife and plants. A species is added to the list when it is determined by the USFWS/NMFS to be endangered or threatened because of any of the following factors:  The present or threatened destruction, modification, or curtailment of its habitat or range;  Overutilization for commercial, recreational, scientific, or educational purposes;  Disease or predation;  The inadequacy

of existing regulatory

mechanisms; and  The natural or manmade factors affecting its survival. Once an animal or plant is added to the list, in accordance with the ESA, protective measures apply to the species and its habitat. These measures include protection from adverse effects of Federal activities. Section 7 (a)(2) of the ESA requires that Federal agencies, in consultation with USFWS and/or the NMFS, ensure that any action they

authorize, fund, or carry

out is not likely

to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. It is the responsibility of the Federal agency

taking the action to assess the effects of their action and to consult with the USFWS and NMFS if it is d etermined that the action “may

affect” listed species or critical habitat. To facilitate APHI S’ ESA consultation process, APHI S met with the USFWS from 1999 to 2003 to discuss factors relevant to APHI S’s regulatory

authority and effects anal ys is for petit ions for nonregulated status, and developed a process for conducting an effects determination consistent with the Plant Protection Act (PPA) of 2000 (Title IV of Public Law 106 - 224). APHIS uses this process to help fulfill its obligations and responsibilit ies under Section 7 of the ESA for biotechnology regulatory actions. APHI S’ regulatory

authority over GE organisms under the PPA is limited to those GE organisms for which it has reason to believe might be a plant pest or those for which APHIS does not have sufficient information to determine that the GE organism is unlikely to pose a plant pest risk (7 CFR § 340.1). APHI S does not have authority to regulate the u se of any herbicide, including gl yphosate or isoxaflutole (IFT) . After completing a PPRA , if APHI S determines that FG72 soy bean does not pose a plant pest risk, then FG72 soy bean would no longer be subject to the plant pest provisions of the Plant Protection Act or to the regulatory requirements of 7 CFR Part 340, and therefore, APHI S must rea ch a determination that the article is no longer regulated.63

As part of its EA analy sis, APHI S is anal yz ing the potential effects of FG72 soy bean on the environment including any potential effects to threatened and endangered species and critical habitat. As part of this process , APHIS thoroughly reviews the GE product information and data related to the organism (generall y a plant species, but may also be other genetically engineered organisms). For each transgene/transgenic plant, APHI S considers the fo llowing information, data, and questions:  A review of the biology and taxonomy

of the crop plant and its sexually compatible relatives;  Characterization of each transgene with respect to its structure and function and the nature of the organism from which it was obtained;  A determination of where the new transgene and its products (if any) are produced in the plant and their quantity ;  A review of the agronomic performance of the plant including disease and pest susceptibilities, weediness potential , and agronomic and environmental impact;  Determination of the concentrations of known plant toxicants (if an y are known in the plant);  Analy sis to determine if the transgenic plant is sexually compatible with any threatened or endangered species (TES ) of plants or a host of an y TES; and  Any other information that may inform the potential for an organism to pose a plant pest risk. In following this review process, APHIS, as described below, has evaluated the potential effects that a determination of no nregulated status of FG72 soy bean may have, if any , on Federally listed TES and species proposed for listing, as well as designated critical habitat and habitat proposed for designation. Based upon the scope of the EA and production areas identified in th e Affected Environment section of the EA, APHIS obtained and reviewed the USFWS list of TES species (listed and proposed) for each state where soy bean is commercially

produced from the USFWS Environmental Conservation Online Sy stem (USFWS, 2012 ) . Prior to this review, APHI S considered the potential for FG72 so yb ean to extend the range of soy bean production and also the potential to extend agricultural production into new natural areas. Bayer CropScience’s stud ies demonstrate that agronomic characteristics and cultivation practices required for FG72 soy bean are essentiall y i ndistinguishable from practices used to grow other soy bean varieties, including other herbicide - tolerant varieties ( Baye r, 2011c ; USDA - APHIS, 2012b ) . Although FG72 soy bean may be expected to replace oth er varieties of so ybean currently cultivated, APHIS does not expec t the cultivation of FG72 soy bean to result in new soy

bean acres to be planted in areas that are not already devoted soy bean production . Accordingly , the issues discussed herein focus on th e potential environmental consequences of the determination of nonregulated status of FG72 so ybean on TES species in the areas where soy bean are currentl y grown. APHI S focused its TES review on the implications of exposure to the 2mEPSPS and HPPD W336 proteins in FG72 soy bean, the interaction between TES and FG72 soy bean, including the potential for sexual compatibility and the ability

to serve as a host for a TES; and potential64

impacts of the use of gl yphosate and IFT herbicides to non - target organisms and the natural environment. **6.1 Potential Effects of FG72 Soybean on TES**  Threatened and Endangered Plant Species The agronomic data provided by Bayer CropScience were used in the APHIS analy sis of the weediness potential for FG72 soy bean and further evaluated for the potential to impact TES. Agronomic studies conducted b y Bayer CropScience tested the h ypothesis that the weediness potential of FG72 so ybean is unchanged with respect to conventional so ybean ( Bayer, 2011c ; USDA - APHIS, 2012b ) . No differences were detected between FG72 soy bean and conventional soy bean in growth, reproduction, or interactions with pests and diseases, other than the intended effect of herbicide tolerance (USDA - APHIS, 2012b ) . Potential of soy bean weediness is low , due to domestication sy

ndrome traits that generally lower overall fitness outside an agricultural environment ( Stewart et al., 2003 ) . Mature so yb ean seeds have no innate dormancy , ar e sensitive to cold, and are not expected to survive in freezing winter conditions ( Raper and Kramer, 1987 ) . Soy

beans have been cultivated around the globe without any report that i t is a serious weed or that it forms persistent feral populations (USDA - APHIS, 2012b ) . Soy bean cannot survive in the majority of the country

without human intervention, and it is easily controlled if volunt eers appear in subsequent crops. APHIS has concluded the determination of nonregu lated status of FG72 soy bean does not present a plant pest risk, does not present a risk of weediness, and does not present an increased risk of gene flow when compared to other currentl y cultivated so yb ean varieties. Based on the agronomic field data and literature survey on soy bean weediness potential, FG72 so ybean is unlikely to affect TES as a troublesome or invasive weed (USDA - APHI S, 2012b ) . APHI S evaluated the potential of FG72 soy bean to cross with a listed species . As discussed above and in the anal ys is of Gene Movement and Weedi ness , APHI S has determined that there is no risk to unrelated plant species from the cultivation of FG72 soy bean. Soy

bean is highl y self - pollinating and can only

cross with other members of Glycine subgenus Soja . Wild soy bean species are endemic in Chin a, Korea, Japan, Taiwan and the former USSR; in the U.S. there are no Glycine species found outside of cultivation and the potential for outcrossing is minimal ( OECD, 2010 ) . After reviewing the list of threatened and endangered plant species in the U.S. states where soybean is grown, APHIS determined that FG72 soy bean would not be sexually compatible with any

listed threatened or endangered plant species prop osed for listing, as none of these listed plants are in the same genus nor are known to cross pollinate with species of the genus Glycine . Based on the agronomic field data , literature survey on soy bean weediness potential, and that there are no TES sexual ly compatible with soy

bean, APHI S has concluded that FG72 soy bean will have no effect on threatened or endangered plant species. Threatened and Endangered Animal Species Threatened and endangered animal species that may be exposed to the gene products in FG72 soy bean would be those TES that inhabit soy bean fields and feed on FG72 soy bean . To identify65

potential effects on threatened and endangered animal species, APHIS evaluated the risks to threatened and endangered animals from consuming FG72 soy bean. S oybean commonly is used as a feed for many livestock. Additionally, wildlife may use so yb ean fields as a food source, consuming the plant , grain, or insects that live on the plants . However, TES generally are found outside of agricultural fields. Few if an y TES are likely to use so yb ean fields because they do not provide suitable habitat. Only whooping crane ( Grus americana ), sandhill crane ( Grus canadensis pulla ), piping plover ( Charadrius melodus ), and interior least tern (Sterna antillarum ) (USFWS, 2011a) . These bird species may visit soy bean fields during migratory periods , but would not be present during normal farming operations ( Krapu et al., 2004 ; USFWS, 2011a) . In a study of so ybean consumption by wildlife in Nebraska, results indicated that soy beans do not provide the high energy food source needed b y cranes and w aterfowl ( Krapu et al., 2004 )

. The Delmarva fox squirrel (Sciurus niger cinereus ), which inhabits mature forests of mixed hardwoods and pines, may be found adjacent to agricultural areas of the Delmarva Peninsula (USFWS, 2011b ) . This species feeds primarily on acorns, nuts, and pine seeds and is not likely to utilize soy

beans to any

extent. The Louisiana black bear ( Ursus americanus luteolus ), occurring in Louisiana, Mi ssissippi, and Texas ( Johnsen et al., 2005 ) , may occasionally forage on so yb ean; however, other crops such as corn, sugarcane, and winter wheat are preferred by this species ( MSU Extension Service, Undated) . FG72 so ybean is genetically engineered to show 2mEPSPS and HPPD W336 protein accumulation, and thus, herbicide tolerance to gl yphosate and IFT. 2mEPSPS has been previously

anal yz ed and approved b y several international regulatory agencies, thus demonstrating that it is not likely to have any

significant impact on animal health ( CFIA, 1998 ; FSANZ, 2001 ; SCF, 2002 ; USDA - APHI S, 1997 ) . The food and feed safety of 2mEPSPS has been assessed in these products and shown t o present no food or feed safety risk. Though HPPD W336 has not previously been evaluated, there is no reason to suspect it would present a risk to non - target organisms . HPPD proteins are ubiquitous in the environment and are not novel. B ioinformatic an al ys is of HPPD W336 showed no significant lengthwise alignment with known toxins or allergens ( Baye r, 2011c ) . FG72 so ybean is within the scope of the FDA policy statement concerning regulation of products derived from new plant varieties, including those produced through genetic engineering. Baye r Crop Science initiated the consultation process with FDA for the commercial distribution of FG72 so ybean and submitted a safety and nutritional assessment of food and feed derived from FG72 so ybean to the FDA on December 3 , 2009 . FDA is currentl y evaluating the submission, and as of March 16, 2012 , has not completed the consultation. Baye r CropScience has presented data on the food and feed safety of FG72 soy bean, evaluating the agronomic and morphological characteristics of FG72 soy bean , including compositional and nutritional characteristics, safety evaluations , and toxicity tests, as compared to a conventional soy bean variety ( Bayer, 2011c ) . Compositional elements, including proximate and fiber components, amino acid and fatty acid content, and antinutrients and isoflavone concentrations , revealed no substantial differences between FG72 soy bean and conventional soy bean varieties ( Baye r, 2011c ) . As discussed in Section 4.4 and 4.6 , the data collected indicate there is no difference in the composition and nutritional quality of FG72 soy bean compared with conventional soy

bean varietie s , apart from the presence of the 2mEPSPS and HPPD W336 proteins . Food Standards Australia New Zealand (FSANZ) also determined that FG72 so ybean66

are compositionall y similar to conventional so ybean, thus suggesting that FG72 soybean is unlikely result in an effect on threatened and endangered animal species ( FSANZ, 2011a , 2011b ) . The results presented by Bayer CropScience show that the incorporation of the 2mepsps and hppd w336 genes and the accompan yi ng activity of the 2mEPSPS and HPPD W336 proteins in FG72 soy

bean does not result in any biologically- meaningful differences between FG72 soy bean and non - GE hy

brid s . Because there is no toxicity or allergenicity potential with FG72 soy bean , there would be no direct or indirect toxicity or allergenicity impacts on wildlife species that feed on soybean or the associated biological food chain of organisms. Therefore, based on these analy ses, APHI S concludes that consumption of FG72 soy bean plant parts (seeds, leaves, stems, pollen, or roots) would have no effect on any listed threatened o r endangered animal species or animal species proposed for listing. After reviewing the possible effects of allowing the environmental release of FG72 so ybean , APHI S has not identified any stressor that could affect the reproduction, numbers, or distributi on of a listed TES or species proposed for listing. APHI S also considered the potential effect of a determination of nonregulated status of FG72 so yb ean on designated critical habitat or habitat proposed for designation, and could identify no differences from effects that would occur from the production of other soy bean varieties. Soy

bean is not considered a particularly compe titive plant species and has been selected for domestication and cultivation under conditions not normally found in natural setting s ( OECD, 2001 , 2010 ) . Soy bean is not sexually

compatible with, or se rves as a host species for, an y listed species or species proposed for listing. Consumption of FG72 soybean by an y listed species or species proposed for listing will not result in a toxic or allergic reaction. Based on these factors, APHI S has conclude d that a determination of nonregulated status of FG72 so yb ean , and the corresponding environmental release of this soy

bean variety will have no effect on listed species or species proposed for listing, and would not affect designated habitat or habitat pro posed for designation. Because of this no effect determination, consultation under Section 7(a)(2) of the Act or the concurrences of the USFWS or NMFS are not required. **6.2 Potential Effects of**  **the use of Glyphosate and Isoxaflutole** APHI S met with USFWS offic ials on June 15, 2011 , to discuss whether APHI S has an y obligations under the ESA regarding anal yz ing the impacts of herbicide use associated with all GE crops on TES. As a result of these joint discussions, USFWS and APHIS have agreed that it is not nece ssary

for APHIS to perform an ESA effects anal ys is on herbicide use associated with GE crops currentl y planted because EPA has both regulatory authority over the labeling of pesticides and the necessary technical expertise to assess pesticide effects on th e environment under FIFRA. APHI S has no statutory authority t o authorize or regulate the use of gl yphosate and IFT , or any

other herbicide, by soy

bean growers. Under APHI S’ current Part 340 regulations, APHI S onl y has the authority to regulate FG72 so yb e an or any GE organism as long as APHI S believes it may pose a plant pest risk. For GE organisms, APHIS has no regulatory jurisdiction over an y other risks associated with GE organisms including risks resulting from the use of herbicides or other pesticide s on those organisms. Nevertheless, APHI S is aware that there may be potential environmental impacts resulting from the use of gly phosate and IFT on FG72 so ybean , including potential impacts on TES and critical habitat, based on assessments67

performed by

the EPA and as available in the peer reviewed scientific literature. APHIS is providing the available information of potential environmental impacts resulting from gl yphosate and IFT use on FG72 soybean below. Endangered Species Protection Program In 1988, Congress enacted Public L aw 100 - 478 (October 7, 1988) to in part address the relationship between ESA and EPA’s pesticide labeling program (Section 1010), which required EPA to conduct a study , and report to Congress, on way s to implement EPA’s endangered species pesticide labeling program in a manner that both complies with ESA and allows people to continue production of agricultural food and fiber. This law provided a clear sense that Congress wanted EPA to fulfill its obligation to conserve listed speci es, while at the same time consider the needs of agriculture and other pesticide users ( 211 FR 66392 ) . In 1988 , EPA established the Endangered Species Protection Program (ESPP) to meet its obligations under the ESA. EPA ’s ESPP site 2 describes the EPA assessme nt process for endangered species. Some of the elements of that process, as reported on the w ebsite, are summarized below. The goal of EPA's ESPP is to carry out its FI FRA responsibilities in compliance with the ESA, without placing unnecessary burden on agriculture and o ther pesticide users consistent with Congress’ intent. EPA is responsible for reviewing pesticide information and data to determine whether a pesticide product may

be registered for a particular use , including those uses associated with the approval of biotechnology

products. As part of that determination, the Agency assesses whether listed endangered or threatened species or their designated critical habitat may be affected by

use of the pesticide product. All pesticide products that EP A determines “may affect” a listed species or its designated critical habitat may be subject to the ESPP. I f limitations on pesticide use are necessary to protect listed species in areas where a pesticide may be used, the information is related through Endangered Species Protection Bulletins. Bulletins identify the species of concern and the pesticide active ingredient that may affect the listed species. They also provide a description of the measures necessary to protect the species and contain a county - level map showing the geographic area(s) associated with the protection measures, depending on the susceptibility

of the species. Bulletins are enforceable as part of the product label ( EPA, 2011a) . EPA TES Evaluation Process EPA evaluates listed species and their critical habitat concerns within the context of pesticide registration and registration review so that when a decision is made, it fully addresses issues relative to listed species protection. If a risk assessment determines that use limitations are necessary to ensure th at legal use of a pesticide will not harm listed species or their critical habitat, EPA may

either change the terms of the pesticide registration or establish geographicall y specific pesticide use limitations ( EPA, 2011a) . The use of an y pesticide in a manner that may kill or otherwi se harm an endangered species or adversel y modify their habitat is a violation of federal law. Pesticides must be used in accordance with the restrictions specified on their product labels.

2 http://www.epa.gov/espp/68

EPA’s review of the pesticide and its registration decision is i ndependent of APHI S’ review and regulatory

decisions under 7 CFR 340. EPA does not require data or analyses conducted b y APHI S to complete its reviews. EPA evaluates extensive toxicity , ecological effects data, and environmental fate, transport and behav ior data, most of which is required under FIFRA data requirements, to assess and determine how a pesticide will move through and break down in the environment. Risks to various taxa, e.g., birds, fish, invertebrates, plants and mammals are routinely asses sed and used in EPA’s determinations of whether a pesticide may be licensed for use in the U.S . EPA’s core pesticide risk assessment and regulatory processes ensure that protections are in place for all populations of non - target species, not just threatene d and endangered species. EPA has developed a comprehensive risk assessment process modeled after, and consistent with, EPA’s numerous guidelines for environmental assessments ( EPA, 2004 ) . The result of an assessment, which may

go through several refinements, is to determine whether the potential effects of a pesticide’s registration to a li sted species will result in either a “no effect” or “may affect” determination. EPA consults on determinations that “may affect” a listed species or adversel y modify

its critical habitat ( EPA, 2012a ) . As a result of either an assessment or consultation, EPA may

require change s to the use conditions specified on the label of the product. When such changes are necessary onl y i n specific geographic areas rather than nationwide to ensure protection of the listed species, EPA implements these changes through geographically- specifi c Endangered Species Protection Bulletins, otherwise, these changes are applied to the label for all uses of the pesticide. Ecological Risks of Gly

phosate and Isoxaflutole Gly phosate and IFT are registered b y the EPA for use in a variety of crops, includin g so ybean ( EPA, 2009c , 2011b ) . Pursuant to FIFRA Section 3(g) , EPA is currently conducting registration reviews for both gl yphosate and IFT to ensure continuing fulfillment of FIFRA registration standards . EPA implements its reregistration eligibility decisions via product reregistration by confirming that required risk reduction measures are reflected on pesticide product labels. The EPA registration reviews for gly phosate and IFT are scheduled to be completed in 2014 and 2017, respectivel y ( EPA, 2009c , 2011b ) . Gly phosate is a non - selective, phosphonomethyl amino acid herbicide that is widely used to control weeds in agricultural and non - agricultural sit es, including forestry , greenhouse, and residential land. Gl yphosate was first registered in 1974, and is currently registered for a variety of aquatic and terrestrial uses on fruits, vegetables, and field crops ( EPA, 2009a) . The effects for gl yphosate are summarized in the RED fact sheet and the preliminary problem formulation for the herbicide ( EPA, 1993 , 2009c ) . IFT was conditionally

registered on September 15, 1998. The conditional registration was extended on April 11, 2002 and unconditionally registered on October 8, 2004 ( Montague, 2012 ) . IFT is currentl y registered as a Restricted Use Pesticide due to non - target ph yt otoxicity concerns. In contrast to General Use Pesticides, IFT must be applied b y or under the supervision of a certified applicator. At p resent, EPA is conducting a registration review for IFT ( EPA, 2010c ) . The results of multiple ecological and human - health risk assessments may be found in Appendix A. In summary , risk to aquatic plants, birds, mammals, invertebrates, and fish were69

below the EPA level of concern (LOC). Additionally , th e EPA human - health risk assessment determined that there is no unreasonable dietary risk surrounding IFT residues at its established tolerances ( EPA, 2011b ) .70

**7 CONSIDERATION OF EXE**  **CUTIVE ORDERS, STAND ARDS, AND TREATIES**  **RELATING TO ENVIRONM ENTAL IMPACTS**  **7.1 Executive Orders with Domestic Implications**  The following executive orders require c onsideration of the potential impacts of the Federal action to various segments of the population.  **Executive Order (EO) 12898 (**  **US -**  **NARA, 2010**

**) , "Federal**  **Actions to Address Environmental Justice in Minority Populations and Low** **- Income Populations,"**  requires Federal agencies to conduct their programs, policies, and activities that substantially

affect human health or the environment in a manner so as not to e xclude persons and populations from participation in or benefiting from such programs. It also enforces existing statutes to prevent minority and low - income communities from being subjected to disproportionately high and adverse human health or environmental effects.  **EO 13045, “Protection of Children from Environmental Health Risks and Safety Risks,”**  acknowledges that children may suffer disproportionatel y from environmental health and safety risks because of their developmental stage, greater metabolic a ctivity

levels, and behavior patterns, as compared to adults. The EO (to the extent permitted by

law and consistent with the agency ’s mission) requires each Federal agency

to identify , assess, and address environmental health risks and safety risks that m ay

disproportionately

affect children. The No Action and Preferred Alternatives were analyzed with respect to EO 12898 and EO 13045. Neither alternative is expected to have a disproportionate adverse effect on minorities, low - income populations, or children. Available mammalian toxicity data associated with the 2mEPSPS and HPPD W336 proteins establish the safety of FG72 soybean and its products to humans, including minorities, low income populations, and children who might be exposed to them through agri cultural production and/or processing. No additional safety precautions would need to be taken. Based on the information submitted by the applicant and reviewed by APHIS, FG72 soy

bean is agronomicall y, phenotyp ically , and biochemicall y comparable to conventional soy bean except for the introduced 2mEPSPS and HPPD W336 proteins. The information provided in the Bayer CropScience petition indicates that the two proteins, 2mEPSPS and HPPD W336, expressed in FG72 so ybean are not expected to be allergenic, tox ic, or pathogenic in mammals ( Baye r, 2011c ; Rouquié et al., 2010 ) . Bayer Crop Science initiated the consult ation process with FDA for the commercial distribution of FG72 so ybean and submitted a safety and nutritional assessment of food and feed derived from FG72 so ybean to the FDA on December 3 , 2009 . FDA is currentl y evaluating the submission, and as of March 16, 2012 , has not completed the consultation. Human toxicity

has also been evaluated b y the EPA in its development of pesticide labels for both herbicides ( 62 FR 17723 ; 76 FR 235 ) . Pesticide labels include use precautions and71

restrictions intended to protect workers and their families from exposures. It is reasonable to assume that growers will adhere to these EPA herbicide use precautions and restrictions. As discussed in Subsection 4.5, Human Health , the potential use of gly phosate and IFT on FG72 soy bean at the proposed application rates would be no more than rates currently approved b y the EPA and should not to have adverse impacts to human health when used in accordance with label instructions. Itis expected that EPA would monitor the use of FG72 soy bean to determine impacts on agricultural practices , such as chemical use , as they hav e done previously

for herbicide - tolerant products. Based on these factors, a determination of nonregulated status of FG72 so yb ean is not expected to have a disproportionate adverse effect on minorities, low - income populations, or children. The following executive order addresses Federal responsibilities r egarding the introduction and effects of invasive species: **EO 1311 (** 

**US -**  **NARA, 2010**

**) , “Invasive Species,”**  states that Federal agencies take action to prev ent the introduction of invasive species, to provide for their control, and to minimize the economic, ecological, and human health impacts that invasive species cause. Soy bean is not listed in the U.S. as a noxious weed species by the Federal government ( ASA, 2011 ) , nor is it listed as an invasive species b y major invasive plant data bases. Cultivated soy bean seed does not usually exhibit dormancy

and requires specific environmental conditions to grow as a volunteer the following ye ar ( OECD, 2010 ) . An y volunteers that may become established do not compete well with the planted crop and are easily managed using standard weed control practices. Soy bean does not possess characteristics su ch as the tolerance for a variety of habitat conditions, rapid growth and reproduction, aggressive competition for resources, and the lack of natural enemies or pests (USDA - APHIS, 2012b ) that would make it a successful invasive plant. Non - engineered so yb eans, as well as other herbicide - t olerant soy bean varieties, are widel y grown in the U.S. Based on historical experience with these varieties and the data submitted by

the applicant and reviewed by APHIS, FG72 soy

bean plants are sufficiently

similar in fitness characteristics to other soy bean varieties currently

grown and are not expected to become weedy or invasive. The following executive order requires the protection of migratory bird populations: **EO 13186 (** 

**US -**  **NARA, 2010**

**) , “Responsibilities of Federal Agencies to Protect**  **Migratory Birds,”** states that federal agencies taking actions that have, or are likely to have, a measurable negative effect on migratory bird populations are directed to develop and implement, within two years, a Memorandum of Understanding (MOU) with the Fish and Wildlife Service that shall promote the conservation of migratory bird populations. Migratory

birds may

be found in soy

bean fields. While soy

bean does not meet the nutritional requirements for man y m igratory birds ( Krapu et al., 2004 ) , they may forage for insects and weed seeds found in and adjacent to so ybean fields. As discussed in Sections 4.4.1 and 4.6 , data submitted by the applicant has shown no difference in compositional and nutritional quality72

of FG72 so yb ean compared with other conventional soybean , apart from the presence of the 2mEPSPS and HPPD W336 proteins . FG72 so yb ean is not expected to be allergenic, toxic, or pathogenic in mammals. Both 2mEPSPS and HPPD proteins have a history of safe consumption in the context of other food and feeds ( Bayer, 2011c ) . Based on APHIS’ assessment of FG72 soy bean , it is unlikely that a determination of nonregula ted status of FG72 s oy

bean would have a negative effect on migratory bird populations. The environmental effects associated with IFT have been anal yz ed b y the EPA ( EPA, 2011b , 2011d) . Testing indicates that ecological toxicity of IFT does not exceed the agency ’s acute or chronic level of concern . Gly phosate is considered no more than slightl y nontoxic to birds ( EPA, 1993 ) . Based on these factors, it is unlikely that the determination of nonregulated status of FG72 so ybean would have a negative effect on migratory bird populations. **7.2 International Implications**  **EO 12114 (** 

**US -**  **NARA, 2010**

**) , “Environmental Effects Abroad of Major Federal Actions”**  requires federal officials to take into consideration any potential environmental effects outside the U.S., its territories, and possessions that result from actions being taken. APHI S has given this EO careful consideration and does not expect a significant environmental impact outside the U.S. in the event of a determination of nonregulated status of FG72 so ybean . All existing national and international regulatory authorities and phy

tosanitary regimes that currentl y appl y to introductions of new soy bean cultivars internationally apply equally to those covered b y an APHIS determination of nonregulat ed status under 7 CFR part 340. Any international trade of FG72 so ybean subsequent to a determination of nonregulated status of the product would be fully subject to national phyt osanitary requirements and be in accordance with phy tosanitary standards de veloped under the International Plant Protection Convention ( IP PC, 2010 ) . The purpose of the IPPC “is to secure a common and effective action to prevent the spread and introduction of pests of plants and pl ant products and to promote appropriate measures for their control” ( IP PC, 2010 ) . The protection it affords extends to natural flora and plant products and includes both direct and indirect damage by pests, including weeds. The IPPC establishes a standard for the reciprocal acceptance of phy tosanitary certification among the nations that have signed or acceded to the Convention (172 countries as of March 2010). In April 2004, a standard for PRA of living modified organisms (LMOs) was adopted at a meeting of the governing body of the IPPC as a supplement to an existing standard, International Standard for Phy tosanitary Measure No. 11 (I SPM - 11, Pest Risk Analy sis for Quarantine Pests). The standard acknowle dges that all LMOs will not present a pest risk and that a determination needs to be made earl y in the PRA for importation as to whether the LMO poses a potential pest risk resulting from the genetic modification. APHI S pest risk assessment procedures for genetically engineered organisms are consistent with the guidance developed under the IPPC. In addition, issues that may relate to commercialization and transboundary movement of particular agricultural commodities produced through biotechnology are bein g addressed in other international forums and through national regulations.73

The Cartagena Protocol on Biosafety is a treaty under the United Nations Convention on Biological Diversity (C BD) that established a framework for the safe transboundary movement, with respect to the environment and biodiversity , of LMOs, which include those modified through biotechnology . The Protocol came into force on September 11, 2003, and 160 countries are Parties to it as of December 2010 ( CBD, 2010 ) . Although the U.S. is not a party to the CBD, and thus not a part y to the Cartagena Protocol on Biosafety, U.S. exporters will still need to comply with those regulations that importing countries which are Parties to the Protocol have promulgated to comply

with their obligations. The first intentional transboundary m ovement of LMOs intended for environmental release (field trials or commercial planting) will require consent from the importing country under an advanced informed agreement (AIA) provision, which includes a requirement for a risk assessment consistent with Annex III of the Protocol and the required documentation. LMOs imported for food, feed, or processing (FFP) are exempt from the AIA procedure, and are covered under Article 11 and Annex II of the Protocol. Under Article 11, Parties must post decisions t o the Biosafety Clearinghouse database on domestic use of LMOs for FFP that may be subject to transboundary

movement. To facilitate compliance with obligations to this protocol, the U.S. Government has developed a website that provides the status of all r egulatory reviews completed for different uses of bioengineered products (NBII, 2010 ) . APHI S continues to work toward harmonization of biosafety and biotechnology consensus documents, guidelines, and regulations, including within the North American Plant Protection Organization (NAPPO), which includes Mexico, Canada, and the U.S., and within the Organization for Economic Cooperation and Development (OECD). NAPPO has completed three modules of the Regional Standards for Ph yt osanitary Measures (RSPM) No. 14, Importation and Release into the Environment of Transgenic Plants in NAPPO Member Countries (NAPPO, 2009 ) . APHI S also participates in the North American Biotechnology Initiative (NABI) , a forum for information exchange and cooperation on agricultural biotechnology issues for the U.S., Mexico, and Canada. In addition, bilateral discussions on biotechnology regulatory issues are held regularl y with other countries inclu ding Argentina, Brazil, Japan, China, and Korea. **7.3 Compliance with Clean Water Act and Clean Air Act**  This EA evaluated the potential changes in so ybean production associated with a determination of nonregulated status of FG72 so ybean (Section 4.2) and determ ined that the cultivation of FG72 so ybean would not lead to the increased production or acreage of so ybean in U.S. agriculture. The herbicide tolerance conferred b y the genetic modification to FG72 so ybean would not result in any

changes in water usage fo r cultivation. As discussed in Section 4.3.2 and 4.3.3, there are no expected negative impacts to water resources or air quality from potential use of gl yphosate or IFT associated with FG72 so yb ean production. Based on these anal ys es, APHI S concludes that a determination of nonregulated status of FG72 so yb ean would compl y with the CWA and the CAA.74

**7.4 Impacts on Unique Characteristics of Geographic Areas**  A determination of nonregulated status of FG72 soy bean is not expected to impact unique characteristics of geographic areas such as park lands, prime farmlands, wetlands, wild and scenic areas, or ecologically critical areas. Baye r CropScience has presented results of agronomic field trials for FG72 soy bean. The results of these field trials demonstrate th at there are no differences in agronomic practices between FG72 and conventional soy bean. The common agricultural practices that would be carried out in the cultivation FG72 so ybean are not expected to deviate from current practices, including the use of EPA - registered pesticides . The product is expected to be deployed on agricultural land currentl y suitable for production of soybean and replace existing varieties, and is not expected to increase the acreage of soy bean production. There are no proposed major ground disturbances; no new phy sical destruction or damage to property; no alterations of property, wildlife habitat, or landscapes; and no prescribed sale, lease, or transfer of ownership of an y property. This action is limited to a determination o f nonregulated status of FG72 soy bean. This action would not convert land use to nonagricultural use and, therefore, would have no adverse impact on prime farmland. Standard agricultural practices for land preparation, planting, irrigation, and harvestin g of plants would be used on agricultural lands planted to FG72 so ybean, including the use of EPA - registered pesticides. The Applicant’s adherence to EPA label use restrictions for all pesticides is expected to mitigate potential impacts to the human envi ronment. With regard to pesticide use, a determination of nonregulated status of FG72 soy bean is likely

to result in changes to the use of IFT on soy bean. The pot ential changes in herbicide use are discussed in Section 4.2.2 . IFT is currentl y registered by the EPA as a restricted use pesticide in soy bean and other crops. APHI S assumes that the EPA label would provide for label use restrictions intended to mitigate potential impacts to the human environment, including potential impacts to unique geographi c areas. As noted above, APHI S further assumes that the grower will closely

adhere to EPA label use restrictions for all pesticides. Potential impacts to geographic areas have been considered b y the EPA in its evaluation of IFT . IFT is currentl y under re gistration review b y the EPA ( EPA, 2011b ) . With regard to the current registrat ion, EPA conducted both human and environmental risk assessments. Although some risks were identified, the EPA determined that these risks could be mitigated by implementing label use restrictions ( EPA, 1997 , 2011c , 2011d , 2012b ) . Additional details regarding the current status of the EPA registration review for IFT may be found in Appendix A. All pesticides distributed or sold in the U.S. are subject to registration by the EPA under authority of FIFRA. Gl yphosate was first registered for use b y the EPA in 1974, and has been assessed several times since then b y the EPA and other Federal Agencies ( EPA, 2009c ) . At present, gl yphosate is currently undergoing registration review b y the EPA; i n 1 993, EPA determined that all currently registered pesticide products containing gly phosate would not pose75

unreasonable risks or adverse effects to humans or the environment, thus permitting its eligibility for the EPA pesticide reregistration program ( EPA, 2009c ) . A preliminary problem formulation has been conducted as part of the registration review of gly phosate by

the EPA, identifying what is currentl y known and uncertainty regardin g the ecological risk, environmental fate, endangered species, and drinking water assessment of gl yphosate and its transformation products ( EPA, 2009c ) . EPA produced an estimated time line for the completion of the gl yphosate registration review, with a final decision due in 2015 ( EPA, 2009a) . Submittals that are relevant to the EPA registration review of gl yphosate can be submitted under the docket designation EPA - HQ - 2009 - 0361 at the Regulations.gov website. Based on these findings, including the assumption that EPA label use instructions are in place to pro tect unique geographic areas and that those label use instructions are adhered to, a determination of nonregulated status of FG72 so yb ean is not expected to impact unique characteristics of geographic areas such as park lands, prime farm lands, wetlands, w ild and scenic areas, or ecologically critical areas. **7.5 National Historic Preservation Act of 1966 as Amended**  The NHPA of 1966 and its implementing regulations (36 CFR 800) require Federal agencies to: 1) determine whether activities they propose constitute "undertakings" that have the potential to cause effects on historic properties and 2) if so, to evaluate the effects of such undertakings on such historic resources and consult with the Advisory Council on Historic Preservation (i.e., State Historic Prese rvation Office, Tribal Historic Preservation Officers), as appropriate. APHI S’ proposed action, a determination of nonregulated status of FG72 soy bean is not expected to adversely

impact cultural resources on tribal properties. Any farming activity

that may be taken by

farmers on tribal lands would only be conducted at the tribe’s request; thus, the tribes would have control over any potential conflict with cultural resources on tribal properties. APHI S’ Preferred Alternative would have no impact on districts, sites, highway s, structures, or objects listed in or eligible for listing in the National Register of Historic Places, nor would it likely cause an y loss or destruction of scientific, cultural, or historical resources. This action is limited to a determination of non - regulated status of FG72 so ybean . APHI S’ proposed action is not an undertaking that may directl y or indirectly cause alteration in the character or use of historic properties protected under the NHPA. In general, common agricul tural activities conducted under this action do not have the potential to introduce visual, atmospheric, or noise elements to areas in which they are used that could result in effects on the character or use of historic properties. For example, there is p otential for increased noise on the use and enjo ym ent of a historic propert y during the operation of tractors and other mechanical equipment close to such sites. A built - in mitigating factor for this issue is that virtually all of the methods involved wou ld only have temporary

effects on the audible nature of a site and can be ended at an y time to restore the audible qualities of such sites to their original condition wit h no further adverse effects. Additionally , these cultivation practices are already b eing conducted throughout the soy

bean production regions. The cultivation of FG72 soy bean is not expected to change an y of these agronomic practices that would result in an adverse impact under the NHPA.76

**8 LIST OF PREPARERS**  **Biotechnology Regulatory Servic es**  David Reinhold, Assistant Director, Environmental Risks Analysis Programs USDA APHIS Khamkeo Vongpaseuth, Ph.D., Environmental Protection Specialist, Environmental Risks Analysis Programs USDA APHIS

Michael Blanchette , Senior Environment al Protection Specialist, Environmental Risks Analysis Programs USDA APHIS

Jo seph Vorgetts , Ph .D., Environmental Protection Specialist, Environmental Risks Analysis Programs USDA APHIS77

**9 REFERENCES**  "Coordinated Framewo rk for Regulation of Biotechnology ," 51 FR (June 26, 1986), pp 23302. "Statement of Policy : Foods Derived from New Plant Varieties," 57 FR (May 29, 1992), pp 22984. "Gl yphosate: Pesticide Tolerances," 62 FR 70 (Aprill 11, 1997), pp 17723. "Mesotrione, Pest icide Tolerances," 74 FR 242 (December 18, 2009), pp 67119. "Isoxaflutole: Pesticide Tolerances," 76 FR 235 (December 7, 2011), pp 76309. "Endangered Species Protection Program Field Implementation," 70 FR 211 (November 2, 2005), pp 66392. Al - Kaisi M, Hann a M, and Tidman M. (2003) Crop Rotation Considerations for 2004 Management Season Rotation. Integrated Crop Management. Retrieved November, 2011 from http://www.ipm.iastate .edu/ipm/icm/2003/12 - 15 - 2003/croprotation.html . Altieri M. (1999) The ecological role of biodiversity in agroecos ys tems. Agriculture, Ecosystems and Environment, 74 (1 - 3), 19 - 31. Aneja V, Schlesinger W, and Erisman J. (2009) Effects of Agriculture upon the Air Quality and Climate: Research, Policy, and Regulations. Environmental Science & Technology, 43 (12), 4234 - 4240. AOSCA. (2010) General IP Protocols Standards. The Association of Official Seed Certifying Agencies. Retrieved November 8, 2010 from http://www.identity

preserved.com/handbook/aosca - general.htm . AOSCA. (2011) A Report of the National Soy bean Variet y Review Board. Association of Seed Certifying Agencies. Retrieved Novemb er, 2011 from http://www.aosca.org/VarietyReviewBoards/Soy bean/2011Soy

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**10 APPENDIX A: ISOXAFLU**  **TOLE –**  **DESCRIPTION AND CURR ENT USES**  Description and Mode of Action Isoxaflutole (IFT) is a s ystemic, broad - spectrum herbicide initially developed for the control of problematic broadleaf and grass weeds in corn (Zea mays ) and sugarcane ( RSC, 2011 ) . Degradation of IFT yi elds two sequential metabolites and may be mediated through metabolic or phy sical/chemical pathway s ( Figure A1 ). Following foliar absorption or root uptake, a rapid and non - enzy matic process sequentially converts IFT into a diketonitrile (DKN) derivative ( Pallett et al., 1998 ) . DKN is the major bioactive principle of IFT, and thus, primaril y responsible for the herbicidal activity

of IFT. DKN is further degraded into a benzoic ac id derivative ( Pallett et al., 1998 ) . Degradation or metabolism of IFT into DKN and the benzoic acid derivative is known to o ccur in soil, plants, and animals ( EPA, 2011c ) . IFT is classified as a Group F2 bleaching herbicide (isoxazole chemical family) under the Herbicide Resistance Action Committee (HRA C). This is a relativel y novel group of herbicides and includes the triketone (e.g., mesotrione and sulcotrione) and p yr azole (e.g., benzofenap, py razoly nate, and py

razoxyfen) chemical families ( HRAC, 2012 ) . In contrast to other carotenoid - inhibiting herbicide groups (e.g., F1 and F3), IFT possesses a unique mode of action (MoA). IFT, through degradation to its bioactive principle, targets 4 - hydroxy phen ylpy ruvate dioxygenase (4 - HPPD). Competitive inhibition of 4 - HPPD by DKN reduces availability of c ellular plastoquinone, an essential co - factor for phy toene desaturase activity

in carotenoid biosy nthesis ( Figure A2 ). Consequently , a depletion of carotenoids impairs chloroplast development, leading to the ty pical bleaching of emerging foliar tissue and stunting of IFT susceptible plant species ( Pallett et al., 2001 ) . Tolerance to IFT may be conferred by

more rapid degradation of DKN benzoic acid derivative in planta ( Pallett et al., 1998 ; RSC, 2011 ) . Herbicidal activity

requires IFT or DKN. Field soil half - life of IFT and DKN are 0.4

– 4.5 and 10

– 39 day s, respec tively ( Table A1 ). Aquatic photoly sis half - life of IFT is 6.7 day s; DKN is relativel y stable in laboratory aquatic conditions, though dissipation half - life from sediment/water s ys tems is 66

– 89 day s ( Ramanarayanan et al., 2005 ) . The benzoic acid derivative is not considered toxicologically significant, and thus, does not display herbicidal activity against plants ( EPA, 2011c ) .

**Figure A 1**  **.** Metabolic/degradative fate of isoxaflutole (IFT) in plants and soil. Reproduced from Pallett et al. (2001).92

**Figure A 2**  **.** Activity

of isoxaflutole (IFT) in plants. (A) Degradation of isoxaflutole yields a diketonitrile derivative in planta . (B) The diketonitrile derivative reduces carotenoid biosy nthesis through inhibition of the 4 - HPPD enzy me, thus precluding the production of the plastoquinol - 9 cofactor necessary for (C) phy

toene desaturase activity . Adapted from Pallett et al. ( 1998 ) .93

**Table A 1**  **.** Summary

of environmental fate information for IFT and DKN.

Reproduced from Ramanarayanan et al. ( 2005 ) . Regulatory

Status of Isoxaflutole The following is a summary of the Environmental Protection Agency (EPA) document entitled Isoxaflutole Summary Document Registration Review: Initial Docket June 2011 ( EPA, 2011a) . Additional section - specific information may be fo und in that document. All pesticides distributed or sold in the U.S. are subject to registration by the EPA under authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Registration of a pesticide is dependent on consideration of sc ientific data demonstrating that a particular pesticide will not cause unreasonable risks to human health, workers, or the environment when used as directed on a product label. IFT was first conditionally registered on September 15, 1998. The condition al registration was extended on April 11, 2002 and unconditionally registered on October 8, 2004 ( Montague, 2012 ) . IFT is currently register ed as a Restricted Use Pesticide due to non - target ph yt otoxicity concerns. In contrast to General Use Pesticides, IFT must be applied by or under the supervision of a certified applicator. At present, active EPA registrations include:  8 Section 3 Registrations.  20 Section 24(c) Special Local Need Registrations.  1 Section 5 Experimental Use Permit (for use on IFT - tolerant soy bean). The Food Quality

and Protection Act of 1996 mandated that the EPA conduct registration reviews of all pesticides distributed o r sold in the U.S. every 15 years. Pursuant to Section 3(g) of FIFRA, EPA initiated a registration review for isoxaflutole in June 2011 (Docket Number:94

EPA - HQ - OPP - 2010 - 0979). EPA has developed an estimated timeline for the isoxaflutole registration revie w process. This is reproduced below in Table A2 : **Table A 2**  **.** Estimated isoxaflutole (IFT) registration review timeline.

**Regist r**  **ation Review for Isoxaflutole -**  **Projected Registration Review Timeline**

**Activities Estimated Date**  Opening the Docket Open Docket and Public Comment Period 2011 - June Close Public Comment 2011 - August Case Development Final Work Plant 2011 - November Issue DCI 2012 - July - Se p. Data Submission 2014 - July - Sept. Open Public Comment Period for Draft Risk Assessment 2016 - Jan. - March Close Public Comment Period 2016 - April - June Registration Review Decision Open Public Comment Period for Proposed Registration Review Decision 2016 - July - Sept. Close Public Comment Period 2016 - Oct. - Dec. Registration Review Decision and Begin Post - Decision Follow - up 2017 Total (years) 6 Conclusions from Previous I soxaflutole Assessments The following is a summary of the EPA do cument Preliminary Problem Formulation for the Environmental Fate and Ecological Risk, Endangered Species, and Drinking W ater Assessments in Support of the Registration Review of Isoxaflutole ( EPA, 2011c ) . Additional information specific to this section may be found in that document. An ecological risk assessment was completed b y the EPA Environmental Fate and Effects Division (EFED) on May 2, 1997 (DP barcodes 225503+) for the proposed r egistration of IFT as a pre - plant or pre - emergence herbicide for the control of grass y and broadleaf weeds in field corn. A brief summary

of the risks from the proposed use of IFT is provided below:  There is a ph yt otoxic risk to non - target aquatic and terrestrial plants from runoff of parent IFT and its degradation products.  There is a ph yt otoxic risk to non - target terrestrial plants from found spray drift of parent IFT.  Minimal adverse effects to non - target plants are expected from ground spray dri ft.  Endangered plant species may be directl y affected by

the use of isoxaflutole.95

 Chronic risks to birds, mammals, shrimp, and estuarine fish cannot be determined because data on the degradation products have not been received. [Note that data submitted s ubsequent to the 1997 assessment has indicated that onl y the Agency’s level of concern (LOC) for chronic risk to estuarine invertebrates is exceeded at rates of application at corn sites. Chronic risks L OCs to birds, mammals, and fish are not exceeded.]  E FED expects that degradation products will persist and accumulate in surface water and shallow ground water surrounding treated areas. [Note that updated data since the 1997 assessment supports this finding. Laboratory studies suggest that DKN and the be nzoic acid derivative are stable to hydrol ys is and photol ysis in aqueous systems and hence pose a possible environmental concern.]  There is a potential risk to other crops from the presence of potentiall y ph ytotoxic degradation products in irrigation water . However, the major areas of corn production that use irrigation (Western U.S. corn belt) have deep aquifers with slow recharge rates that are not likel y to have sufficient concentrations of the degradation products to adversel y affect other crops. In o ther parts of the U.S., where corn is also grown and where shallow ground water is used for irrigation, sporadic irrigation is used for other crops. Crops such as so ybean, which are rotated with corn and are sensitive to irrigation waters containing IFT r esidues, could be adversely affected. Estimated maximum concentration of IFT residues in ground water exceeded the phyt otoxic triggers to non target plants (e.g., other crops) up to 4,500 times, presuming that the degradation products are as toxic as parent IFT. [Note that updated data since the 1997 assessment indicate that IFT’s terminal metabolite, the benzoic acid derivative, does not demonstrate phy totoxicity for terrestrial plants. A developmental toxicity study in rats conducted with the benzoic acid derivative has been submitted to the Agency (MRID 45655906). The results of the study

show that in the presence of maternal toxicity at the highest doses tested (750 mg/kg/day), there was no teratogenicity or developmental toxicity . These results an d those of other toxicology studies and plant studies on the compounds suggest that the benzoic acid derivative of IFT is not toxicologicall y significant.] On April 16, 2010, EFED completed an ecological risk assessment for an Experimental Use Permit (EUP) request from Bayer CropScience for IFT use on IFT - tolerant soy bean. Additionally , EFED conducted another ecological risk assessment expanding the geographic extent of corn and considered the use of IFT on soy bean. In these ecological risk assessments, I FT and its bioactive principle, DKN, were assessed for potential risk to non - target organisms. The conclusions are briefly summarized below:  The Agency ’s LOC for terrestrial non - target plants was exceeded for runoff and spray drift exposure routes.  Runoff from so ybean and/or corn fields may contain residues of IFT and DKN. These waters, if used for irrigation on non - target plants (crops) may exceed the Agency ’s LOC for non - target plants by

up to 310X.  The Agency ’s LOC for aquatic non - target plants was not exceeded for listed and non listed species near soy

bean fields.  The Agency ’s acute or chronic LOCs for birds and mammals (listed and non - listed) were not exceeded.96

 The Agency ’s acute or chronic LOCs for fish or invertebrates (freshwater or estuarine) (lis ted and non - listed) were not exceeded. On September 9, 2011, the EPA Health Effects Division (HED) completed a human - health risk assessment entitled Isoxaflutole. Section 3 Registration for Use on Soybeans. Human -Health Risk Assessment ( EPA, 2011b ) as a result of a request from Bayer CropScience t o amend 40 CFR 180.537 by

establishing tolerances for combined residues of IFT and DKN in or on soy bean . Additional information specific to this section may be found in that document. Acute and chronic toxicity

profiles are presented below in Tables A3 and A4 . **Table A 3**  **.** Acute toxicity profile of isoxaflutole (IFT) and degradation products.

Guideline No./Study Type MRID No. Results Toxicity Category Isoxaflutol e Technical 870.1100/Acute oral toxicity 43573212 LD 50 >5000 mg/kg IV 870.1200/Acute dermal toxicity 43573213 LD 50 >2000 mg/kg III 870.1300/Acute oral toxicity 43573214 LC 50 >5.23 mg/L IV 870.2400/Primary eye irritation 43573215 Non - irritating IV 87 0.2500/Primary dermal irrigation 43573216 Non - irritating IV 870.2600/Dermal sensitivity 43573217 Non - sensitizer N/A DKN Technical 870.1100/Acute oral toxicity 43904810 LD 50 >500 0 mg/kg IV Benzoic Acid derivative Technical 870.1100/Acute oral toxicity 43904812 LD 50 >5000 mg/kg IV **Table A 4**  **.** Subchronic and chronic toxicity and genotoxicity

profi le: Isoxaflutole ( IFT ) and products. Guideline

No./Study Type MRID No.

(Year)/Doses/Classification Results

Isoxaflutole 870.3250 43573219 NOAEL = 1000 mg/kg/day. 21 - day dermal (r at) LOAEL not observed.

0, 10, 100, or 1000 mg/kg/day.

**Acceptable (guideline)**97 Guideline No./Study Type MRID No.

(Year)/Doses/Classification Results 870.3700 43573220 Maternal NOAEL = 1000 mg/kg/day. Developmental toxicity (rat) 0, 10, 100, or 1000

mg/kg/day. Maternal LOAEL = 500 mg/kg/day based on increa sed incidence of clinical signs and decreased body weight, body - weight gains and food consumption. **Acceptable (guideline)** Developmental NOAEL = 10 mg/kg/day. Developmental LOAEL = 100 mg/kg/day base on decreased fetal body weights and increased inc idences of skeletal anomalies. Developmental toxicity (rabbit) 43904808

0, 5 , 20, 100 mg/kg/day. Maternal LOAEL = 100 mg/kg/day based on increased incidence of clinical signs, decreased body weight gains, and food consumption. **Acceptable (guideline)** Developmental NOAEL not observed. Developmental LOAEL = 5 mg/kg/day base on increased incidence of fetuses with 27th pre - scaral vertebrae. 870.3800 43904809 Maternal NOAEL = 1.76 mg/kg/day. 2 - generation reproduction (rat) 0/0, 0.45/0.46, 1.76/1.79,

17.4/17.7, or 414/437 mg/kg/day (M/F). Maternal LOAEL = 17.4 mg/kg/day based on increased liver weights and hypertrophy in both sexes and generations. Reproductive NOAEL = 437 mg/kg/day. Reproductive LOAEL not observed. Offspring NOAEL = 1.7 6 mg/kg/day. **Acceptable (guideline)** Offspring LOAEL = 17.4 mg/kg/day based on reduced litter survival in both generations (F 1 and F 2 pups). 870.4100 43573218 Maternal NOAEL = 20 mg/kg/day. Chronic toxicity (dogs) 0, 240, 1200, 12000, or 30000

ppm (0, 8.56/8.41, 44.81/45.33, 453/498, or - /1254 mg/kg/day [M/F]). Maternal LOAEL = 100 mg/kg/day based on increased incidence of clinical signs, decreased body weight gains, and food consumption. **Acceptable (guideline)** Developmental NOAEL not observed. D evelopmental LOAEL = 5 mg/kg/day base on increased incidence of fetuses with 27th pre - scaral vertebrae. 870.4200 43904807 NOAEL = 25 ppm (3.24/4 mg/kg/day (M/F). Carcinogenicity (mice) 0, 25, 500, or 7000 ppm (0/0,

3.2/4, 64.4/77.9, or 977.3/1161.1 mg/kg /day [M/F]). LOAEL = 500 ppm (64.4/77.9 mg/kg/day (M/F), based on decreased body weight gains, increased liver weights, and increased incidences of histopathological liver changes. **Acceptable (guideline)** Liver tumors observed at HDT.98 Guideline No./Study Type MRID No.

(Year)/Doses/Classification Results 870.4300 43 904806 NOAEL = 2 mg/kg/day. Chronic toxicity/ Carcinogenicity (rats) 0, 0.5, 2, 20, or 500

mg/kg/day. LOAEL = 20 mg/kg/day, based on liver, thyroid, ocular, and nervous system toxicity (M) and liver toxicity (F). **Acceptable (guideline)** Liver and thyroi d tumors observed at HDT.

870.5100 43588002 Negative. In vitro bacterial reverse mutation ( S. typhimurium ) Up to insoluable ( > 500

 g/plate) concentrations =/ - S9. **Acceptable (guideline)** 870.5300 43573222 Negative. In vitro mammalian gene mutation (L5178Y mouse lymphoma) Up to insoluable ( > 150

 g/plate) or soluable ( < 75 mg/plate) concentrations +/ - S9. **Acceptabl e (guideline)**  870.5375 43573221 Negative. In vitro mammalian chromosomal aberration (lymphocytes) Up to insoluable ( > 300  g/ml

- S9; < 600  g/ml +S9. **Acceptable (guideline)** 870.5395 43573223 Negative. In vivo mammalian cytogenetics (mou se micronucleus) Up to 5000 mg/kg.

**Acceptable (guideline)** 870.6200 43904804 NOAEL = 125 mg/kg/day. Acute neurotoxicity (rat) 0, 125, 500, or 2000

mg/kg/day. LOAEL = 500 mg/kg/day based on significant decreases in hind limb grip strength and landin g food splay on day 15.

**Acceptable (guideline)**99 Guideline No./Study Type MRID No.

(Year)/Doses/Classification Results 870.6200 43904805 NOAEL = Not observed. Subchronic neurotoxicity (rat) 0, 25, 250, or 750 mg/kg/day. LOAEL = 25 mg/kg/day based on significant decreases in mean hind limp grip strength during both trial s and week 13 and a non - significant decrease in mean forelimb grip strength at week 13. **Acceptable (guideline)**

870.6300 45215701 (2000) Maternal NOAEL = 25 mg/kg/day. Developmental Neurotoxicity (rat) 0, 5, 25, or 250 mg/kg

bw/day. Maternal LOAEL = 250 mg/kg/day based on increased incidence of clinical signs, decreased body weight, body - weight gains, and food consumption Tentative offspring NOAEL = 25 mg/kg/day. **Unacceptable (guideline) -**  morphometric measurements not perfo rmed Tentative offspring LOAEL = 250 mg/kg/day based on decreased body weight and brain weight (no effects at lower doses). 870.7485 Metabolism (rat) 43573224 Rapidly and extensively absorbed and metabolized. 1 and 100 mg/kg (single dose) 1 mg/ kg/day (15 - day repeated dosing). DKN represented 70% or more of the radioactivity excreted in the urine and feces. The benzoic acid derivative was more polar. Elimination was rapid and dose dependent. The majority of the radiolabel was eliminated in the first **Acceptable (guideline)** 24 and 48 hours for the low and high dose groups, respectively. The extensive

43904815 Comparative metabolism study **Unacceptable (non**   ** guideline)** systemic clearance of the radiolabel was reflected in the low levels of radioactivity found in tissues at 168 hours post dosing. Sex - related differences were observed in the excretion and distribution pattern among high - dose rats. The elimination half- lives were similar among single low and high dose groups , with an estimated mean blood half- life of 60 hours. No sex differences were observed in the metabolism of 14 C isoxaflutole.100 Guideline No./Study Type MRID No.

(Year)/Doses/Classification Results 870.7600 Dermal penetration 44044702 3.46% absorption at 0.865 mg/cm 2 after 10 hours. 0.865, 7.32, or 79 mg/cm 2

. **Acceptable (guideline)** 870.7800 48283101 NOAEL = 4000 ppm (279 mg/kg/day). Immunotoxicity LOAEL = not identified.

0, 160, 800, or 4000 ppm (0. 6. 57. or 279 mg/kg/day). **Acceptable (guideline)** Mechanistic studies 43904816 - 4390 4820 Investigated ocular toxicity, tyrosinemia, and mode of action of liver and thyroid tumor formation in rats and mice DKN 870.5100 43904811 Negative. In vitro bacter ial reverse mutation ( S. typhimurium ) Up to 500  g/plate +/ - S9.

**Acceptable (guideline)**

Benzoic Acid derivative 870.3100 43904813 (1995) NOAEL = 15000 ppm (1117.79/1268.73 mg/kg/day [M/F]). 28 - day oral rat (range - find ing) 0, 150, 500, 5000, or 15000

ppm (0.0, 11,14/12.68, 37.57/42.7, 376.96/421.53 or 1117.79/1268.73 mg/kg/day [M/F]) LOAEL not observed.

**Acceptable (guideline)** 870.3100 45655903 (1998) NOAEL = 12000 ppm (769/952 mg/kg/day [M/F]). 90 - day oral (rat) 0, 1200, 4800, or 12000 ppm

(0/0. 73.2/93.1, 306/371, or 769/952 mg/kg/day [M/F]). LOAEL not observed.

**Acceptable (guideline)**101 Guideline No./Study Type MRID No.

(Year)/Doses/Classification Results 870.3700 45655906 Maternal NOAEL = 75 mg/kg/day. Developmental toxicity rats (gavage) 0, 75, 250, or 750 mg/kg/day. Maternal LOAEL = 250 mg/kg/day based on clinical signs (salivation and piloerection around time of treatment), decreased body - weight change, decreased corrected body - weight change, and decreased food consumption. **Acceptable (guideline)** Devel opmental NOAEL = 750 mg/kg/day. Developmental LOAEL not observed. 870.5100 43904814 Negative. In vitro bacterial reverse mutation ( S. typhimurium ) Up to cytotoxic

concentrations ( > 2500  g/plate) +/ - S9. **Acceptable (guideline)** 870.5300 4454303 Negative. In vitro mammalian gene mutation (CHO/HGPRT) Up to > 2700  g/ml +/ - S9.

**Acceptable (guideline)** 870.5375 44545301 Negative. In vitro mammalian chromosomal aberration (CHO cells) Up to > 2710  g/ml +/ - S9.

**Acceptable (guideline)** 870.5395 44545301 Negative. In vivo mammalian cytogenetics (mouse micronucleus) 0, 500, 1000, or 2000 mg/kg.

**Acceptable (guideline)** As a result of this human - health assessment, HED determined that there is no residue chemistry , toxicological or occupational/residential exposure issue that would preclude establishment of an unconditional registration for IFT and its metabolites. These tolerances include:  HED - recommended tolerance fo r the combined residue of IFT and DKN on soy bean is 0.05 ppm.  HED - recommended tolerance the combined residue of IFT and DKN on aspirated grain fractions of so yb ean is calculated as 0.30 ppm.102

Current Use and Usage Information At present, IFT is registered a s a Restricted Use Pesticide (RUP) in field corn by the EPA under authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) ( EPA, 2011a) . In contrast to General Use Pesticides, IFT may only be applied by

certified applicators or under the supervision of a certified applicator ( EPA, 2012 ) . Additionally , an experimental use permit for use o f IFT on IFT - tolerant soy bean was approved on April 27, 2010 ( Bayer, 2011a) . IFT may be found in the following herbicide formulations: Balance Pro ® ; Balance Flexx ® (IFT + cy prosulfamide); Corvus TM (IFT + thiencarbazone + cy prosulfamide); and Radius TM (IFT + flufena cet) ( Baye r, 2011c ) . Additionally , DuPont also produces PrequelTM (IFT + Rimsulfuron) ( DuPont, 2012 ) . IFT registrations for field corn can onl y be used in the following states: Arkansas, Colorado, Illinois, Indiana, Iowa, Kansas, Kentucky, Miss ouri, Montana, Nebraska, North Dakota, Ohio, Oklahoma, Penns yl vania, South Dakota, Tennessee, Texas, and Wyoming ( Baye r, 2011b ) . The listed states participate in developing/following label restrictions to mitigate the possibility of adverse effects to non - target plants. An example of restrictions for use in field corn is presented in Table A5 . More label information can be found at: http://iaspub.epa.gov/apex/pesticides/f?p=PPL S:1:1863164510650266 IFT registration for IFT - tolerant soy bean can be used in the same states as field corn, except Arkansas, Oklahoma, and Texas ( Baye r, 2011a ) . The listed states also participate in developing/following label restrictions to mitigate the possibility of adverse e ffects to non - target plants. Table A6 presents a summary of proposed IFT use in IFT - tolerant soy bean and an example of restrictions for use in IFT - tolerant so ybean is presented in Table A7 . Restrictions for IFT use in so ybean are the same as corn, including the maximum application rate of 3.0 fluid ounces/year. More label information can be found at: http://iaspub.epa.gov/apex/pesticides/f?p=PPL S:1:1863164510650266103

**Table A 5**  **.** Specific use directions for Balance® PRO herbicide alone as part of a planned sequential weed control program. Source: Bayer (2011b).

**Table A 6**  **.** Proposed directions for use of isoxaflutole (IFT) on isoxaflutole - tolerant soy bean varieties. Source: EPA (2011b).104

**Table A 7**  **.** Specific use directions for Balance® PRO herbicide applied alone, as a tank - mix, or as part of a planned sequential program for weed control in isoxaflutole (IFT) tolerant soy bean varieties. Source: Bayer (2011a).105

**References** Baye r. (2011a) Balance PRO Herbicide Registration. Bayer CropScience. Retrieved January , 2012 from http://www.epa.gov/pesticides/chem_search/ppls/000264 - 00600 - 20111107.pdf

. Baye r. (2011b) Bayer Balance PRO. Bayer CropScience. Retrieved January , 2012 from http://www.epa.gov/pesticides/chem_search/ppls/000264 - 00600 - 20110103.pdf . Baye r. (2011c) Petition for the Determination of Nonregulated Status for Event FG72. Submitted by I sabelle S. Coats, Regulatory Affairs Manag er. Bayer Crop Science (See Table: http://www.aphis.usda.gov/biotechnology /not_reg.html) . DuPont. (2012) Prequel Label. Dupont. Retrieved January , 2012 from http://www2.dupont.com/Production_Agriculture/en_US/label_msds_info/labels/SL 1664A.pdf

. EPA. (2011a) Isoxaflutole Summary Document Registration Review: Initial Docket June 2011. Environmental Protection Agency . EPA. (2011b) Isoxaflutole. Section 3 Registration for Use on So ybeans. Human - Health Risk Assessment. Environmental Protection Agency . EPA. (2011c) Preliminary Problem Formulation for the Environmental Fate and Ecological Ri sk, Endangered Species, and Drinking Water Assessments in Support of the Registration Review of Isoxaflutole. Washington DC: Environmental Protection Agency. EPA. (2012) Restricted - Use Pesticides. Environmental Protection Agency. Retrieved January , 2012 from http://www.epa.gov/oppfead1/safety/ applicators/restrict.htm . HRAC. (2012) Classification of Herbicides According to Modes of Action. Herbicide Resistance Action Committee. Retri eved January , 2012 from http://www.plantprotection.org/hrac/MOA.html . Montague K. (2012, 2/17) Personal Communication. Pallett KE, Cramp SM, Little JP, Veerasekaran P, Crudace AJ, and Slater AE. (2001) Isoxaflutole: the background to its discovery and the basis of its herbicidal properties. Pest Management Science, 57(2), 133 - 142. Pallett KE, L ittle JP, Sheekey M, and Veerasekaran P. (1998) The Mode of Action of Isoxaflutole: I. Phy siological Effe cts, Metabolism, and Selectivity . Pesticide Biochemistry and Physiology, 62 (2), 113 - 124. Ramanarayanan T, Narasimhan B, and Srinivasan R. (2005) Characterization of Fate and Transport of Isoxaflutole, a Soil - Applied Corn Herbicide, in Surface Water Using a Watershed Model. Journal of Agricultural and Food Chemistry, 53 (22), 8848 - 8858. RSC. (2011) I soxaflutole. Royal Society of Chemists. Retrieved November, 2011 from http://www.rsc.org/pdf/general/11 isoxaf.pdf .106

**11 APPENDIX B: GLYPHOSA**  **TE –**  **SUMMARY OF ENVIRONME NTAL FATE AND**  **TOXICITY PROFILE** Gly phosate acid is non - selective, s ys temic foliar herbicide used to control weeds in agricultural and non - agricultural sites, including forestry , greenhouse, and r esidential sites. Gly phosate functions as a specific inhibitor of the enzy me, 5 - enolpy

ruvylshikimate 3 - phosphate sy nthase (ESPS), effectivel y precluding plant aromatic amino acid s ynthesis (e.g., tyrosine, try ptophan, and phen yl alanine) and leading to plant cell death ( EPA, 2009 , 2011 ) . The following is a summary of the environmenta l fate and toxicity profile from the EPA document Preliminary Problem Formulation for the Ecological Risk and Drinking W ater Exposure Assessments for Glyphosate and its Salts ( EPA, 2009 ) . Additional information form this section may

be found in that document.  Based on the EPA Reregistration Eligibility Decision in 1993 ( EPA, 1993 ) , EPA concluded that direct risks to birds, mammals, invertebrates, and fish would be minimal. Under certain con ditions, gl yphosate may pose a risk to aquatic plants. Additionally , endangered plants and the Houston Toad may be at risk from gly

phosate use.  In 2003, the USDA Forest Service conducted a risk assessment for gl yphosate (USDA FS, 2003 ) . Based on the available data, USDA - FS concluded that the risks due to gl yphosate were minimal for mammals, birds, fish, invertebrates, and aquatic plants. However, at an application rate of 7 lbs. a.e./acre, the acute exposure slightly exceeded the acute LC 50 and exceeded the L C 50 by a factor of two for more tolerant and less tolerant freshwater fish, respectivel y. These values were determi ned, however, from a worse - case scenario where severe rainfall occurred in an area where runoff is favored. Additionally , tolerant terrestrial plants did not appear at risk from low - boom spray application of gly

phosate at distances of 25 feet or greater. For more sensitive plants, this distance increased to approximately 1000 feet. No risks to terrestrial plants from runoff were expected, due to the high sorption of gl yphosate to soil particles.  In 2004, EPA assessed the potential of gly phosate to affe ct 11 federall y listed Pacific salmonids ( Patterson, 2004 ) . The conclusion of that assessment was that gly phosate may , but is not likely , to negatively affect the salmonids based on acute toxicity to fish for application rates above 5 lbs. a.i./acre. The EPA also concluded that there would be no effect from gl yphosate on salmonids at application rates below 5 lbs. a.i./acre.  In 2008, EPA assessed the potentia l direct and indirect effects on the California red legged frog (Rana aurara draytonii ) resulting from the use of gly phosate on agricultural and non - agricultural sites ( Carey et al., 2008 ) . The EPA concluded that there was no direct effect on the aquatic - phase California red - legged frog for an y terrestrial or aquatic uses of gly

phosate. The terrestrial phase California red - legged frog may be at risk following direct chronic exposure to gl yphosate at application rates of 7.5 lbs. a.e./acre and above. Additionall y, terrestrial - phase amphibians may be at risk following acute exposure to one particular formulation (Registration number 524 - 424) at 1.1 lbs formulation/ac re. Indirect effects to the aquatic phase California red - legged frog, based on reduction in the prey

base, may

occur with aquatic non - vascular plants that are107

managed at an application rate of 3.75 lbs. a.e./acre. Indirect effects to the California red l egged frog, based on reduction in prey base, may

occur with small insects at any registered rate; large insects at an application rate of 7.95 lbs. a.e./acre; terrestrial phase amphibians following chronic exposure gly phosate at application rates of 7.5 lb s. a.e./acre and above; at an acute exposure to the formulation listed above; and, mammals following chronic exposure at application rates of 3.84 lbs. a.e./acre. Indirect effects to both the aquatic - and terrestrial - phase California red - legged frog, base d on habitat effects, may

occur following the management of aquatic plants with gl yphosate. **Table B 1**  **.** Physical and chemical properties of gly phosate.108

**Table B 2**  **.** Enviro nmental fate data for gl yphosate.109

**Table B2 continued.**110

**Table B 3**  **.** Aquatic toxicity profile for gl yphosate and/or its salts.111

**Table B 4**  **.** Terrestrial toxicity profile for gl yphosate and/or its salts.112

**References** Carey S, Crk T, Flaherty C, Hurley P, Hetrick J, Moore K, and Termes S. (2008) Risks of Gly phosate Use to Federally

Threatened California Red - legged Frog. Environmenal Protection Agency . EPA. (1993) R.E.D. Fa cts - Gly phosate. Environmental Protection Agency . Retrieved Match, 2012 from http://www.epa.gov/oppsrrd1/REDs/factsheets/0178fact.pdf . EPA. (2009) Registration Review - Preliminary P roblem Formulation for the Ecological Risk and Drinking Water Exposure Assessments for Gl yphosate and Its Salts (PC Code 417300, 103601, 103604, 103607, 103608, 103613, 103603, 103605, 128501). Environmental Protection Agency . EPA. (2011) Isoxaflutole Summ ary Document Registration Review: Initial Docket June 2011. Environmental Protection Agency . Patterson M. (2004) Gl yphosate: Anal ys is of Risks to Endangered and Treatened Salmon and Steelhead. Environmental Production Agency . Retrieved March, 2012 from http://www.epa.gov/oppfead1/endanger/litstatus/effects/gl yphosate - anal ys is.pdf . USDA - FS. (2003) Gly

phosate - Human Health and Ecological Risk Assessment Final Repo rt. SERA RT 02 - 43 - 09 - 04a. United States Department of Agriculture Forest Service. Retrieved March, 2012 from http://www.fs.fed.us/r5/hfqlg/publications/herbicide_info/2003_gl yphosate.pdf .113

**12 APPENDIX C: SUPPLEME**  **NTAL FIGURES AND TAB LES** 

**Figure C 1**  **.** Global distribution of herbicide - resistant bioty pes, 2010. Color intensity is associated with an increasing number of herbicide - resistant bioty pes. Reproduced from Heap (2012).

**Figure C 2**  **.** Gl obal herbicide - resistant bioty pes b y mode of action, 1950

– 2010. Reproduced from Heap (2012).114

**Table C 1**  **.** Soy

bean acreage in U.S. states, 2010. **State 2000**  **2005 2010**  Alabama 160,000 145,000 345,000 Arkansas 3,150,000 3,000,000 3,150,000 Colorado - - - Connecticut - - - Delaware 213,000 182,000 173,000 Florida 15,000 8,000 23,000 Georgia 140,000 175,000 255,000 Illinois 10,450,000 9,450,000 9,050,000 Indiana 5,480,000 5,380,000 5,330,000 Io wa 10,680,000 10,000,000 9,730,000 Kansas 2,500,000 2,850,000 4,250,000 Kentucky 1,160,000 1,240,000 1,390,000 Maine - - - Maryland 515,000 470,000 465,000 Massachusetts - - - Michigan 2,030,000 1,9 90,000 2,040,000 Minnesota 7,150,000 6,800,000 7,310,000 Mississippi 1,580,000 1,590,000 1,980,000 Missouri 5,000,000 4,910,000 5,070,000 Montana - - - Nebraska 4,575,000 4,660,000 5,100,000 New Jersey 98,000 91,000 92,000 New Mexico - - - New York 132,000 188,000 279,000 North Carolina 1,360,000 1,460,000 1,550,000 North Dakota 1,850,000 2,900,000 4,070,000 Ohio 4,440,000 4,480,000 4,590,000 Oklahoma 290,000 305,000 475,000 Oregon - - -115 **State 2000**  **2005 2010**  Pennsylvania 385,000 420,000 495,000 South Carolina 430 ,000 420,000 455,000 South Dakota 4,370,000 3,850,000 4,140,000 Tennessee 1,150,000 1,100,000 1,410,000 Texas 260,000 230,000 185,000 Vermont - - - Virginia 480,000 510,000 540,000 Washington - - - West Virginia 15,000 17,000 18,000 Wisconsin 1,500 ,000 1,580,000 1,630,000 U.S. Total 72,408,000 71,251,000 76,610,000 Source : USDA -NASS ( 2011a) . **Table C 2**  **.** Irrigation of soy bean acres in U .S. states, 2007. **State Acreage**  **Irrigated acreage Percent irrigated**  **acreage** Alabama 179,673 2,124 1.18 Arkansas 2,819,478 1,843,478 65.38 Colorado 2,948 1,882 63.84 Connecticut 294 (D) - Delaware 155,548 24,528 15.77 Florida 12,066 212 1.76 Illinois 8,293,711 70,513 0.85 Indiana 4,783,821 82,454 1.72 Io wa 8,612,810 50,481 0.59 Kansas 2,591,428 261,588 10.09 Maine 766 - - Maryland 386,604 20,663 5.34 Massachusetts 247 - - Michigan 1,715,427 66,556 3.88 Minnesota 6,273,919 92,688 1.48116 **State Acreage**  **Irrigated acreage Percent irrigated**  **acreage** Mississippi 1,431,085 483,004 33.75 Missouri 4,672,738 365,094 7.81 Montana 409 (D) - Nebraska 3,834,855 1,570,110 40.94 New Jersey 79,218 4,730 5.97 New Mexico (D) - - New York 199,775 (D) - North Carolina 1,380,792 13,830 1 North Dakota 3,073,792 13,830 0.45 Ohio 4,236,337 1,056 0.02 Oklahoma 180,878 12,497 6.91 Oregon (D) (D) - Pennsylvania 431,053 (D) - South Carolina 442,461 8,943 2.02 South Dakota 3,222,872 52,661 1.63 Tennessee 976,011 4,077 0.42 Texas 93,453 16,269 17.41 Vermont 2,011 - - Virginia 490,396 8,007 1.63 Washington 725 385 53.10 West Virginia 13,717 - - Wisconsin 1,363,124 24,855 1.82 U.S. Total 63,915,821 5,237,075 8.19 Source : USDA -NASS ( 2011b ) .117

**Table C 3**  **.** Common soy

bean insect pests. **Common name (Scientific name)** Pod, stem, and seed feeders Southern green stink bug ( Nezara viridula ) Three - cornered alfalfa hopper ( Spissistilus festinus) Green stink bug ( Acrosternum hilare ) Le sser cornstalk borer ( Elasmopalpus lignisellus ) Brown Stink Bug ( Euschistus servus/Euschistus spp. ) Dectes stem borer ( Dectes texanus taxanus ) Bean leaf beetle ( Ceratoma trifurcata ) Seedcorn maggot ( Delia plautura ) Corn earworm ( Helicoverpa zea ) Foliage feeders Soybean looper ( Pseudoplusia includens ) Twospotted spider mite ( Tetranychus urticae ) Velvetbean caterpillar ( Anticarsia gemmatalis ) Mexican bean beetle ( Epilachna varivestis ) Green cloverworm ( Plathypena scabra ) Potato leafhopper ( Emopasca fabae ) Beet armyworm ( Spodoptera exigua ) Silverleaf whitefly ( Bemisia argentifolii ) Fall armyworm ( Spodoptera frugiperda ) Bandedwinged whitefly ( Trialeurodes abutilonea ) Yellow striped armyworm ( Spodoptera ornithogalli ) Grasshopper ( Melanoplus spp. ) Yellow woolybear ( Spilosoma virginica ) Soybean thrips ( Neohydatothrips variabilis ) Root and nodule feeders Soybean nodule fly ( Rivellia quadrifasciata ) White grubs ( Phyllophaga spp. ) Banded cucumber beetle ( Diabrotia balteata ) Grape colas pis ( Colaspis brunnea ) Source: Boethel ( 2004 ) . **Table C 4**  **.** Common weeds in soy bean production: Midwest Region. Reproduced From Monsanto ( 2010 ) . Number provided in parentheses is the number of states out of the thirteen total states in the Midwest Region that reported each weed. Foxtail spp. (12) Ragweed, giant (3) Dandelion (1) Pigweed spp. (11) Shattercane (3) Johnson grass (1) Velvetleaf (11) Quackgrass (3) Milkweed, honeyvine (1) Lambsquaters (10) Buckwheat, wild (2) Nightshade, hairy (1) Cocklebur (9) Crabgrass, spp (2) Oats, wild (1) Ragweed, common (7) Kochia (2) Pokeweed, common (1) Smartweed spp (6) Mustard, wild (2) Prickly sida (1) Morning glory spp. (5) Nightshade, Eastern black (2) Proso millet, wild (1) Sunflower, spp (5) Palmer amaranth (2) Sandbur, field (1) Waterhemp spp. (5) Canada thistle (1) Venice mallow (1) Horseweed (marestail) (3) Chickweed (1) Volunteer cereal (1) Panicum, fall (3) Cupgrass, woolly (1) Volunteer corn (1)118

**Table C 5**  **.** Common weeds in soy bean production: Eastern coastal Region. Reproduced From Monsanto ( 2010 ) . Number provided in parentheses is the number of states out of the thirteen total states in the Eastern C oastal Region that reported each weed. Ragweed, common (8) Jimson weed (4) Dandelion (1) Cocklebur (7) Sicklepod (3) Goosegrass (1) Morning glory spp. (7) Florida pusely (2) Nightshade, Eastern Black (1) Crabgrass spp. (6) Johnson grass (2) Panicum, Tex as (1) Foxtail spp. (6) Palmer amaranth (2) Prickly sida (1) Lambsquaters (6) Quackgrass (2) Shattercane (1) Pigweed spp. (6) Arrowleaf sida (1) Signalgrass, broadleaf (1) Velvetleaf (6) Beggarweed, Florida (1) Smartweed spp (1) Nutsedge spp. (5) Burc ucumber (1) Panicum, fall (5) Canada thistle (1) **Table C 6**  **.** Common weeds in soy bean production: Mid - south Region. Reproduced From Monsanto ( 2010 ) . Number provided in parentheses is the number of states out of the thirteen total states in the Mid - south Region that reported each weed. Morning glory spp. (5) Pigweed spp. (3) Ragweed, common (1) Prickly sida (5) Crabgrass spp. (2) Ragweed, giant (1) Johnson grass (4) Palmer amaranth (2) Red rice (1) Sicklepod (4) Cocklebur (1) Smartweed (1) Signalgrass, broadleaf (4) Copperleaf, hophorn (1) Spurge, nodding/hyssop (1) Barnyard grass (3) Florida pusely (1) Spurge, prostrate (1) Hemp sesbania (3) Horseweed (marestail) (1) Nutsedge spp. (3) Poinsettia, wild (1)119

**References** Boethel D. (2004) Integrated Management of Soybean Insects. In, Soybeans: Improvement, Production, and Uses. Third Edition (pp. 853 - 881). R Al - Amoodi, J Harper, R Wilson and R Shoemaker (Eds.). Madison, WI : Ameri can Society of Agronom y. Crop Science Society of America. Soil Science Society of America. Monsanto. (2010) Petition for the Determination of Nonregulated Status for Improved Fatty Acid Profile MON 87705. Submitted by Regulatory

Affairs Manager. The Mons anto Company (See Table: http://www.aphis.usda.gov/biotechnology /not_reg.html) . USDA -NASS. (2011a) Quick Stats 1.0. Retrieved November, 2011 from United States Department of Agriculture - National Agricultural Statistics Service http://www.nass.usda.gov/QuickStats/Create_Federal_All.jsp . USDA -NASS. (2011b) Quick Stats 2.0. Retrieved November, 2011 from United States Department of Agriculture http://www.nass.usda.gov/Data_and_Statistics/Quick_Stats/index.asp .120

**13 APPENDIX D: SOYBEAN**  **COMMODITY PRODUCTION** Commodity

Production Industry : Contracts are typically signed with growers when the specialty seed is purchased, obligating the growers to supply harvested seed under given conditions, such as all the soy

bean from a certain number of committed acres, specifying methods of productions and where the seed may

be sold, and establishing standards for the product when delivered. Contracts between the growers and an oil crusher may be signed, and after oil is crushed, the bulk oil processer companies arrange for sale to food or industrial buye rs ( ADM, 2006 ) . In the production of so yb ean seed for commodity or IP use, two industries are relevant. The first are businesses that sell seed for planting and applied chemicals, and the second are the buye rs of soy bean grain, the elevators. Both are needed to produ ce specialty soy products. When a grower purchases specialty seeds, he will be required to produce his soybeans for a designated elevator, and a contract with the elevator may specify means of production, crop performance and seed quality . Soy bean meal is the most important product deriving from soy bean seed and meal is the product that drives demand for soybean rather than oil. Oil comprises only 19% b y weight of the soy bean ( Ty son et al., 2004 ) . Thus, oil is a minor product of the crushing industry . As noted earlier, so yb ean meal is predominantly fed to animals while a small percentage is used for human consumption or industrial uses. Animal Feed Users : Animal feeds are the major use for soy bean meal, consuming about 77 percent of the total meal produced ( Soy Connection, 2011a) . The mixed rations for poultry , hogs, cattle, dairy

cows, domestic pets, and farmed fish often are formulated with soy bean meal. In 2008/2009, 10.3 million metric tons of meal was used in broiler rations, 9.1 milli on tons in hog rations and 1.9 million tons in beef rations (USB, 2010 ) . The other animal industries used 7.7 million tons for feeding operations. A variety of industries prepares, formulates, manuf actures and distributes animal feeds. Fresh and Processed Food Users : Various industries supply all types of processed and fresh foods derived from soy

bean ( Soy

Connection, 2011b ) . Grain products from soy include flours, pas ta, bread, waffles, and cereal. Oil products include margarines, salad and frying oils. Simulated meats include soy burgers, hot dogs, nuggets, and tofu. Vegetable uses include edamame, and soy

nuts. Simulated milk products include soy milk beverage, so y cheese, yo ghurt, and ice cream. Oil Users : In the production of oils from oilseed such as so ybean, two general industries can be identified ( O'Brien, 2004 ) . The first is the crusher/refiner whose focus may be oil feedstocks deriving from a single source of oilseed. The crushing business, which extracts c rude vegetable oil and meal, sends the oil to refiners, or may retain some for industrial and fuel users. The refiners may

be separate phy sicall y from the crushing business and may subject oil to including degumming, refining, bleaching, dewaxing, fractio nating, interesterifying, hydrogenating, changing the melting points of the oil, blending and deodorizing. The refiner may then package the liquid oil, produce margarines, shortening, and bulk fats or oils. Specialty oils, when produced at facilities making commodity oils, are produced in batches or only semi continuously and supply

specialized needs of the food processing or other commercial products industries. The121

total value of products from the primary soy bean processing industry

was estimated at $18 billion (US Census Bureau, 2009 ) . The second industry

comprises the many

value - added businesses which may employ starting feedstocks from soy

seed or other oilseed sources, and which manufacture products from commodity

oil or a variety

of specialized oils. Th ese include food and industrial product manufacturers in a wide variety of offerings to businesses, retailers and consumers. Foods : The properties of oils that are used in foods may vary widel y, and these result from the fatty acids that are incorporated into constituent trigl yc erides. The positions of the fatty acids within the triglycerides also may help determine these properties. Specific fatty acids have associated chemical properties (such as reactivity) and phy sical properties (such as melting points), as well as other functional properties which are taken into account when they are incorporated into foods. Oils high in unsaturated fatty acids are useful in making solid fat products such as baking shortenings ( O'Brian, 2009a) , while oils low in satur ated fats are useful for salad oils ( O'Brian, 2009b ) . Trans - esterification may be used to change the positions of the fatty acids in the triglyceride, or exchange one for another, all of which can alter oil properties. When fatty

acids are oxidized, flavor is a dversel y affected, and this is referred to as “reverted” oil. Reverted soy

bean oil has a “beany” or “grassy” flavor ( O'Brien, 2004 ) . Oils that are high in poly unsaturates are the most susceptible to such oxidation among food oils. L inoleic and particularl y linolenic in traditional soybean oil are those fatty acids most easily

oxidized. Hydrogenation of soy

bean salad oils reduces the content of linolenic acid, a poly unsaturated oil, and ty pically , will reduce it from 9% to 3% ( O'Brien, 2004 ) . Reducing the unsaturated linolenic acid decreases the possibility that off - flavors will develop. This process also produces “trans” fatty acids, which have been linked to deleterious consequences for human health, and have encouraged the development of other so ybean lines with altered fatty acid content. Industrial (Non - Edible Products) Use : Soy bean oil is a feed sto ck for numerous products used in several domestic industries. Biodiesel provides the largest market for so yb ean oil (Table D1) , with production at 1,192 million liters in 2010 (USB, 2011 ) . Soy bean biodiesel in 2007 had a value of $1.09 billion dollars. By comparison, fuel ethanol had a value of $6.6 billion (US Census Bureau, 2009 ) . S oaps, amines, f atty a cids and o leo c hemicals is the second largest consumer of industrial soy bean oil at 1 40 ,000 metric tons ( see Table D1) ( USB, 2011 ) . Paints, coatings and inks rank third, with 118,000 metric tons, and p olyols and p lastics with 115,000 metric tons. Lu

bricants and w orking f

luids produced a total 26,000 metric tons, and solvents and s pecialty uses a total of 22,000 tons.122

**Table D 1**  **.** In dustrial soybean o il production 2008 - 2009.

**Product Soybean oil**  **( m**  **illion m**  **etric t**  **ons)** Biodiesel 0.8 22 Soaps, Amines, Fatty Acids & Oleo Chemicals 0.1 40 Paints, Coatings & Inks 0. 115 Polyols & Plastics 0. 127 Total Industrial Meal 0. 055 Lubricants & Working Fluids 0. 02 6 Solvents & Specialty 0. 022 Other Industrial Products 0. 010 Total Industrial Whole Bean <0.001 Source: USB ( 2011 ) .123

**References** ADM. (2006) ADM to Process Monsanto’s VistiveTM L ow Linolenic Soy beans at Indiana Facility. Retrieved November, 2011 from http://www.adm.com/en US/news/_layouts/PressReleas eDetail.aspx?ID=170 . O'Brian R. (2009a) Baking Shortenings. In, Fats and Oils: Formulating and Processing for Applications ). Boca Raton: CRC Press. O'Brian R. (2009b) Liquid Oils. In, Fats and Oils: Formulating and Processing for Applications ). Boca Rot an, FL: CRC Press. O'Brien R. (2004) Fats and Oils - Formulating and Processing for Applications . Boca Raton, FL : CRC Press. Soy Connection. (2011a) Food and Fuel: Meeting the Challenges of Feeding the World and Creating Renewable Fuels. United Soy bean Board. Retrieved November, 2011 from http://www.soyconnection.com/soy bean_oil/pdf/foodvsfuel_soy _biofuels.pdf

. Soy Connection. (2011b) Soyfoods Guide 2011. United Soy bean Board. Retrieved November, 2011 from http://www.soyconnection.com/soyfoods/pdf/soyfoods_guide.pdf . Ty son S, Bozell J, Wallace R, Petersen E, and Moens L . (2004) Biomass oil anal ys is: Research needs and recommendations. NREL/TP - 510 - 34796. National Renewable Energy Laboratory . Retrieved December 2011 from http://www.nrel.gov/docs/fy04osti/34796.pdf . US Census Bureau. (200 9) 2007 Economic Census, Sector 31: Manufacturing: Industry Series: Products Statistics for the United States: 2007 , Fats and Oils: Oilseed Crushings. United States Census Bureau. Retrieved December, 2011 from http://factfinder.census.gov/servlet/IBQTable?_bm=y& - geo_id=& - fds_name=EC0700A1& - _skip=100& - ds_name=EC0731I2& - _lang=en . USB. (2010) Animal Agriculture Economic Analy sis: 1999 - 2009. United Soy bean Board. Retrieved December, 2011 from http://unitedsoy

bean.org/images/uploads/multimedia/National_Animal_Agriculture_Econ omic_Analy sis_2010.pdf . USB. (2011) Online Market View Database. Domestic Data 2008/2009. United Soy bean Board. Retrieved October, 2011 from http://usb.adayana.com: 8080/usb/reports/domestic_data.jsp .